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Envigo Pharmaceutical Development

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East Millstone, New Jersey, US

About Envigo Pharmaceutical Development

Divison of: Envigo

From bench to patient, the journey is a long and oft-times winding road. It is one you cannot walk alone. You want to choose a partner that understands science, the product development cycle, marketing, and the regulatory process. As one of the world's largest therapeutic product development Contract... Show more »

From bench to patient, the journey is a long and oft-times winding road. It is one you cannot walk alone. You want to choose a partner that understands science, the product development cycle, marketing, and the regulatory process. As one of the world's largest therapeutic product development Contract Research Organizations, Envigo has a long heritage of providing a comprehensive range of high quality, non-clinical development services to pharmaceutical companies around the world.

Our integrated network of scientific, technical, and regulatory experts has the breadth and depth of biopharmaceutical experience to help you reach your R & D milestones and support your global regulatory submissions. We set the highest standards of quality and service, offering a broad range of practical support, consultancy and problem solving all customized to meet your specific research requirements. Envigo is recognized as one of the foremost testing laboratories and our dedicated, exceptional staff is committed to providing you with exactly what you need, from outsourced single studies, through managing complex programs, to the development of long term strategic partnerships.

For 60 years our scientists have helped customers develop safe and effective new medicines that have made a real difference to people’s lives. When you walk with Envigo, you can trust that you have a partner who knows the journey. Envigo has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories, and three subsidiaries: GFA, NDA Analytics and LSR associate

Our Pharmaceutical Services:

  • Discovery Services & Lead Candidate Selection
  • Bioanalytical
  • Non-Clinical Safety Assessment
  • Regulatory Affairs
  • Product Development & Strategy
  • Clinical Manufacturing
  • Support Archiving
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Our Services (157)


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In vivo Genotoxicity Testing

Price on request

First do no harm. It is not enough that your drug is effective – it must be safe. Envigo has been providing genetic toxicology services to our drug development customers for more than 30 years under our dedicated team of scientists with vast combined experience in all aspects of genetic toxicology. Whether you are a small,... Show more »

First do no harm. It is not enough that your drug is effective – it must be safe. Envigo has been providing genetic toxicology services to our drug development customers for more than 30 years under our dedicated team of scientists with vast combined experience in all aspects of genetic toxicology. Whether you are a small, exciting biotech startup or a large multinational pharmaceutical corporation, we offer expertise to help you ensure that the products you are developing are doing all the good you know they can.

  • Ames Test
  • Mouse Lymphoma Assay
  • Chromosome aberration test
  • In Vitro Micronucleus Test
  • In Vivo Micronucleus Test
  • Unscheduled DNA Synthesis Test (in vitro and in vivo)
  • Comet Assay (in vitro and in vivo)
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Hamster Rabbit Guinea pig Mouse Rat

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In vitro Skin Models

Price on request
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
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Multiplex PK Assays

Price on request
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eCTD Services

Price on request
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ICH Stability Testing

Price on request
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In vitro Percutaneous Absorption Studies

Price on request
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Medical Device Clinical Trials

Price on request
Request a quote for more information about this service.

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In vitro Skin Irritation/Sensitization Testing

Price on request
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
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In vivo Toxicity Testing

Price on request
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Influenza Animal Models

Price on request
  • Influenza - tissue burden and biomarker endpoints
  • Influenza - tissue burden and biomarker endpoints
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Influenza

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Genotyping and Gene Expression Assays

Price on request
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Biopharmaceutical Development

Price on request

With certain biopharmaceuticals nearing patent expiration, the opportunities to launch a biosimilar product are growing. But many competitors are going to quickly jump on those opportunities. How will you bring your biosimilar to the market faster? How will you quickly and accurately prove that your product resembles the... Show more »

With certain biopharmaceuticals nearing patent expiration, the opportunities to launch a biosimilar product are growing. But many competitors are going to quickly jump on those opportunities. How will you bring your biosimilar to the market faster? How will you quickly and accurately prove that your product resembles the innovator drug in efficacy and structure? At Envigo, our extensive experience in biopharmaceutical analytics ensures you have a reliable ally to help secure the potential of your product.

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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Vaccine Testing Services

Price on request

With the wide variation in types of therapeutic vaccines, your development and corresponding analytical needs are growing more complex. Whether you are focused on oncology, allergy, addiction, or any number of other therapeutic areas, your vaccine formulation and development program depend on a partner with deep and diverse... Show more »

With the wide variation in types of therapeutic vaccines, your development and corresponding analytical needs are growing more complex. Whether you are focused on oncology, allergy, addiction, or any number of other therapeutic areas, your vaccine formulation and development program depend on a partner with deep and diverse experience including whole organisms, toxoids, recombinant protein subunit vaccines, conjugate vaccines, virus-like particles and DNA vaccines. Even if you are working on more sophisticated variants, Envigo has the expertise to build and implement the most appropriate analytical services to support your regulatory submission.

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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Antibody-Drug Conjugate (ADC) Analysis

Price on request

Your Antibody Drug Conjugate (ADC) offers the potential to be one of an exciting next generation of cancer therapeutics, combining tumor-associated antigen targeting with a potent cytotoxic drug. But as a specialized class of biopharmaceutical, ADCs require a unique combination of assays that can characterize the mononclonal... Show more »

Your Antibody Drug Conjugate (ADC) offers the potential to be one of an exciting next generation of cancer therapeutics, combining tumor-associated antigen targeting with a potent cytotoxic drug. But as a specialized class of biopharmaceutical, ADCs require a unique combination of assays that can characterize the mononclonal antibody backbone, chemical linker and cytotoxic component. We understand what you need and how to implement the most appropriate and optimal analytics program. In the complex world of biopharmaceutical development, Envigo strives to help you achieve the potential for your product, and ultimately improve overall patient health.

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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Drug Development

Price on request
Request a quote for more information about this service.
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Compendial Testing

Price on request
Request a quote for more information about this service.
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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qPCR

Quantitative PCR
Price on request

For nucleic acid quantitation, real-time quantitative Polymerase Chain Reaction (qPCR) is the gold standard. Whether you are interested in quantifying DNA, RNA analysis, residual DNA analysis, or adventitious agent testing, Envigo is here to support you. With decades of experience in cGMP qPCR analysis, Envigo has built a... Show more »

For nucleic acid quantitation, real-time quantitative Polymerase Chain Reaction (qPCR) is the gold standard. Whether you are interested in quantifying DNA, RNA analysis, residual DNA analysis, or adventitious agent testing, Envigo is here to support you. With decades of experience in cGMP qPCR analysis, Envigo has built a cutting-edge infrastructure to support you, including a team dedicated to the delivery of your qPCR requirements operating in a bespoke facility.

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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Batch Release Testing

Price on request

The critical quality attributes of your product need to be demonstrated and are required to fall into a very narrow range. Recognizing that future GMP manufacture of the product will depend on QC release testing of the batch/lot, there is no room for error. Envigo is highly experienced in QC release testing having provided... Show more »

The critical quality attributes of your product need to be demonstrated and are required to fall into a very narrow range. Recognizing that future GMP manufacture of the product will depend on QC release testing of the batch/lot, there is no room for error. Envigo is highly experienced in QC release testing having provided services for numerous biopharmaceuticals from Phase I to commercial release. Moreover, under the auspices of the GMP Quality Assurance team, Envigo is one of the few companies that can provide both physicochemical, compendial and potency/bioassay testing.

Envigo’s QC release testing analytical methods enable you to address the following:

  • Appearance and Description
  • Identity
  • Purity and Impurities
  • Potency
  • Quantity
  • General/compendial tests
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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FRET

Fluorescence resonance energy transfer
Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Cell Migration Assays

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

In vitro Reporter Gene Assays

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

In vitro Immunogenicity Assays

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

NAb Assays

Neutralizing Antibody Assays
Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Flow Cytometry

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Luciferase Assays

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Signaling Pathway Analysis

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

ADCC and CDC Assays

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Custom Cell-Based Assay Development

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Ligand Binding Assays

Price on request

Ligand binding assays are an essential component of your biosimilar release and stability testing program. To support you, Envigo has extensive experience in the development of reliable and robust cGMP ligand binding assays even if using them as a substitute for your potency bioassay. Our scientists have successfully developed... Show more »

Ligand binding assays are an essential component of your biosimilar release and stability testing program. To support you, Envigo has extensive experience in the development of reliable and robust cGMP ligand binding assays even if using them as a substitute for your potency bioassay. Our scientists have successfully developed and operated dozens of LBAs for biopharmaceuticals like yours, ranging from pre-clinical to marketed products.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Cell Proliferation Assays

Price on request

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities... Show more »

Whether you are looking for an in vivo or in vitro potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Effector function
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • Programmed Cell Death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • Viral challenge
  • In vivo activity
  • Immunogenicity
  • Neutralizing antibody (Nab)

We can also provide the following assay readouts for your biologic product:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

UV-VIS Spectroscopy

Price on request
Request a quote for more information about this service.
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Chemical Stability Testing

Price on request

How stable is your product? Can it remain intact and potent during storage? To ensure the safety and efficacy of the product, Envigo helps you to determine shelf life and temperature effects on your GMP grade material. If your product is in early development, Envigo can also help you evaluate the intrinsic stability, determine... Show more »

How stable is your product? Can it remain intact and potent during storage? To ensure the safety and efficacy of the product, Envigo helps you to determine shelf life and temperature effects on your GMP grade material. If your product is in early development, Envigo can also help you evaluate the intrinsic stability, determine degradation pathways, elucidate the structures of the degradative products and establish which analytical techniques are stability-indicating.

Envigo can support any of the four types of stability studies:

  • Real-time stability study
  • Accelerated stability study
  • Forced degradation stability study
  • Photostability study

Regulatory guidance for stability studies is provided by the following:

  • ICH Q1A(R2) Stability testing of new drug substances and products
  • ICH Q1B Photostability testing of new drug substances and products
  • ICH Q5C Stability of Biotechnology/Biological Products

Envigo is highly experienced in all forms of stability study, from formal GMP studies to R&D based forced degradation studies, and that expertise enables us to meet your unique study needs. Our experienced stability scientists can design flexible, phase specific protocols to suit the intended purpose for the data and ensure it is fit for purpose. Additionally, Envigo operates a GMP compliant stability facility, including stability chambers set at all the recommended ICH accelerated conditions and standalone units that can be set to new temperatures and humidity, as required. The stability facility is operated under the auspices of the GMP Quality Assurance Group.

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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Quality Assurance

Price on request

A robust quality system is at the core of your drug development program because your processes and procedures must hold up to the scrutiny of a regulatory inspection. Envigo has a staff of quality gurus to make sure you have the appropriate Standard Operating Procedures (SOPs), working processes and systems in place to ensure your... Show more »

A robust quality system is at the core of your drug development program because your processes and procedures must hold up to the scrutiny of a regulatory inspection. Envigo has a staff of quality gurus to make sure you have the appropriate Standard Operating Procedures (SOPs), working processes and systems in place to ensure your quality imperatives are being followed. Our quality experts make sure you take appropriate steps to maintain the integrity of your study data, and to help you make adjustments and pull your systems back in line in the face of deviations and things outside of your normal processes and procedures.

Do you know what inspectors look for? We do. At Envigo, we have the confidence to make these claims because we employ a team of Quality Assurance professionals who will work with you to establish and manage a robust Quality System.

Our QA/QC services:

  • Core SOP and standard form writing and maintenance
  • Development of internal Quality Management Systems
  • Continuous improvement initiatives
  • Auditing services:
    • CRO Systems
    • Laboratory
    • Clinical Study Phase GCP site
    • Vendors
    • Internal Systems
  • Trial Master File
  • Inspection Readiness Training
  • Assistance with completion of MHRA Compliance Report
  • Disaster Recovery and Business Continuity Planning
  • Quality Control (QC) of documentation
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Pharmacovigilance and Post-Authorization Safety Studies (PASS)

Price on request

No matter what part of the drug development cycle you are in, you need to keep a sharp eye on the way your safety data is collected and reported. Envigo employs a specialized Pharmacovigilance Group committed to supporting the set up and management of your PV reporting system and to ensuring you meet agency reporting... Show more »

No matter what part of the drug development cycle you are in, you need to keep a sharp eye on the way your safety data is collected and reported. Envigo employs a specialized Pharmacovigilance Group committed to supporting the set up and management of your PV reporting system and to ensuring you meet agency reporting requirements.

We deliver pharmacovigilance support in both clinical and peri- / post-marketing settings, and we have the necessary experience to assume the role of Responsible Person for EudraVigilance and Qualified Person for Pharmacovigilance.

With extensive changes currently occurring within the pharmacovigilance legislation and regulations, we are well positioned to navigate you through the requirements for post-marketing pharmacovigilance, including preparation and maintenance of the Pharmacovigilance System Master File.

What you can expect:

From protocol review through to receipt, processing and reporting of Serious Adverse Events (SAEs), we are able to provide tailored support for clinical trials, particularly focusing on:

  • First-in-human and other early phase studies
  • Blinded studies
  • Unblinded studies with robust systems in place to ensure that the distribution of unblinded data is limited to the appropriate parties E2B compliant ICSRs
  • Periodic line-listings
  • Development Safety Update Reports
  • Periodic Safety Update Reports

Our Pharmacovigilance services:

  • Training – an up-to-date overview of current safety reporting requirements, delivered at your premises
  • SOPs – provision and management of SOPs appropriate to your organization’s needs
  • Registration of sponsor companies to EVG
  • Receipt and processing of Serious Adverse Events
  • MedDRA coding of event terms and production of CIOMS / MedWatch forms
  • Reporting of SUSARs to Regulatory Agencies and Research Ethics Committees / IRBs
  • Aggregate safety reports
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Clinical Trial Management

Price on request

The demands of a well-run clinical program require scientific and medical knowledge and a superior organizational capacity for managing the necessary documentation. Envigo’s Clinical Support Group is a team that understands the science, the medicine and the regulations that guide them. Our Clinical Support Group has expertise in... Show more »

The demands of a well-run clinical program require scientific and medical knowledge and a superior organizational capacity for managing the necessary documentation. Envigo’s Clinical Support Group is a team that understands the science, the medicine and the regulations that guide them. Our Clinical Support Group has expertise in immunology, biologic development and analysis, and in nearly every therapeutic category, most recently adding oncology to our list of clinical expertise.

Whether or not you are the biggest fish in the pond, your promising drug or device can make a big splash in the marketplace. Envigo is one of the world’s leading clinical research organizations with a distinguished heritage working with small, medium and “big” pharma clients, as well as medical device firms. We have a staff of experts who are committed to designing and executing clinical trials for our customers, no matter your size and no matter where you are.

Envigo has a proven record of supporting customers from feasibility evaluation to clinical methodology studies. We have experience across a range of indications, and we are fully conversant in the special study requirements for healthy volunteers and patients, New Chemical Entities (NCEs), biologics and advanced therapies.

We actively manage all aspects of studies throughout the UK, US, Europe, Africa, and Australia. Also, for companies that have no European footprint we offer Legal Representative Services.

Our Clinical Research Capabilities:

  • Feasibility evaluation and project planning
  • Study start-up – regulatory, REC / IRB and site approvals
  • Project execution – management of budget, timelines and quality
  • Site management – Site selection, site start-up, monitoring and close out
  • Vendor identification and management
  • Medical Writing (Investigator Brochure, Clinical Trial Protocol, Patient Information Sheet / Consent Form, Clinical Study Report)
  • Clinical methodological studies (biomarkers), building translational scientific best practice into our clinical research – to deliver robust studies specializing in biotech and mid cap pharmaceutical companies
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Pharmaceutical Product Development Consulting

Price on request

To bring your novel product to market, it is essential you have a clear plan of action for the road ahead with a firm grasp of the national legislation and local regulatory guidelines of your market territory. You need a strategic partner who can provide tailored expert advice on your product pipeline to establish an optimal... Show more »

To bring your novel product to market, it is essential you have a clear plan of action for the road ahead with a firm grasp of the national legislation and local regulatory guidelines of your market territory. You need a strategic partner who can provide tailored expert advice on your product pipeline to establish an optimal development plan to meet your goals. Envigo is just such a detail-oriented partner.

For each tactical path, we will provide a cost efficient plan with expected milestones and predicted timings to ensure success. Through our continued surveillance of industry regulations, we deliver our customers a plan for the future. With this in mind, our team stands ready to support your needs whether they are for product development in Europe, the US, Japan or you are forging market inroads elsewhere.

Our Product Development services include:

  • In-depth regulatory strategy advice
  • Best route to market recommendations
  • Formal project planning and analysis for non-clinical and clinical Phase I-III projects
  • Study design and protocol preparation
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Regulatory Affairs Consulting

Price on request

When you are dealing with the different regulatory requirements around the globe relating to all phases of your product’s approval and marketing, you want to work with the most highly qualified, experienced and approachable team you can find. After all, you are under pressure from the regulators. You want a confident partner at... Show more »

When you are dealing with the different regulatory requirements around the globe relating to all phases of your product’s approval and marketing, you want to work with the most highly qualified, experienced and approachable team you can find. After all, you are under pressure from the regulators. You want a confident partner at your side.

Envigo’s regulatory affairs team is equipped with the knowledge and skills to provide your company with a comprehensive understanding of current regulatory guidelines and procedures. Our experienced consultancy group provides practical advice and support to our drug development customers in moving products from early concept to marketing authorization. With a proven track record of success across the world, we can help you throughout the entire lifecycle of your product to achieve your goals in a fast, low risk and efficient manner. With offices in the UK, US and Japan, we provide regulatory services throughout the ICH regions, and we can offer a global regulatory service through our affiliations in other non-ICH regions.

What you can expect:

  • Preparation of Marketing Authorization Applications, Clinical Trial Authorization applications and INDs * Preparation of requests for Scientific Advice from FDA, EMA and EU National Authorities
  • Support for customers in Regulatory Authority meetings; advice on regulatory strategy; due diligence on existing data packages
  • Preparation of Orphan Drug Designations in EU and US, Pediatric Investigation Plans and Drug Master Files
  • Advice on individual study designs, taking into account product type and therapeutic class, and review and interpretation of study data
  • Regulatory support for the development of devices, drug/device combinations and borderline products
  • Clinical trial legal representative services for non-EU companies and US Agent services for non-US companies

Products:

We work with a full range of medicinal products including New Chemical Entities (NCEs), biologics, advanced therapies and generics. We have experience with the following product types:

  • Small molecules
  • Protein-based therapeutics
  • DNA-based therapeutics
  • Drug delivery systems
  • Re-profiled known Active Pharmaceutical Ingredients (APIs)
  • Generics
  • Drug-Device combinations
  • Herbal medicines

Procedures:

We can maximize the success of your product by assisting you with:

Clinical Trials (Phase I, II & III):

  • Due diligence
  • Agency and working party meetings e.g ITF meeting
  • Scientific Advice / Protocol Assistance
  • CTA / IND applications and maintenance
  • Pediatric Investigation Plans
  • Orphan Drug Designation
  • Fast Track Applications / Special Protocol Assistance
  • Marketing Authorization Applications
  • Pre submission meetings
  • MAA/NDA/BLA preparation and filing
  • eCTD and NeeS Submissions
  • Drug Master Files
  • Responses to agency questions
  • Post Marketing Approval
  • License variations
  • Renewals
  • Line extensions
  • Submissions to additional countries (MRP)
  • Product maintenance
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Fluorescence-Based Microscopy

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Special Slide Staining

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Whole Slide Imaging/Digital Slide Scanning

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Scanning Electron Microscopy (SEM)

Scanning Electron Microscopy services
Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Microautoradiography

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Immunostaining

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Paraffin Embedding

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Cryosectioning

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Tissue Sectioning

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Animal Necropsy Services

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Tissue Cross Reactivity Studies

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Veterinary Pathology

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

ic

Histopathological Examination

Price on request

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help... Show more »

We understand that customization is key in pathology services. Your needs and objectives are unique, and you need a partner that can offer a broad range of pathology services with the ability to meet your special requirements. From routine to special processing techniques, Envigo provides the expertise and track record to help you in your safety assessment and other studies. We routinely process over 60,000 slides/month, each evaluated by our in-house pathologists and always meeting the highest of quality standards.

Envigo’s Pathology Services include the following:

  • Routine necropsy, histology and histopathology of all laboratory animals and special species (e.g., fish, snail, frog, goat, cow)
  • Necropsy at customer sites
  • Special embedding and techniques
    • Tissue freezing for immunohistochemistry and cryostat frozen sectioning
    • Resin embedding (e.g., for neurotoxicity and downstream electron microscopy imaging) and semi-thin sectioning/staining
    • Diamond saw and accelerated decalcification procedures for bones
  • Manual and automated immuno-staining with a wide range of validated antibodies
  • Human and Animal Tissue cross-reactivity studies (ICHS6(R1))
  • Microautoradiography and receptor autoradiography techniques
  • Microscopy
    • Remote slide viewing
    • Fluorescence microscopy
    • Scanning electron microscopy
  • Extensive case collection for training pathologists
  • Peer review by senior pathologists

With an average of 20 years experience, our pathologists offer expertise with a wide variety of species, and are readily available to discuss treatment-related findings and suggest further investigations where needed.

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Animal Surgery

Price on request

With a seemingly infinite number of options for developing a surgical model, where do you begin? Choosing the right model is critical to getting the most out of your surgical exploration and you need a partner who not only has vast surgical expertise, but a focus on you and meeting your specific objectives. Whether you are... Show more »

With a seemingly infinite number of options for developing a surgical model, where do you begin? Choosing the right model is critical to getting the most out of your surgical exploration and you need a partner who not only has vast surgical expertise, but a focus on you and meeting your specific objectives. Whether you are looking for routine infusion catheter implantation or complex, customer-specific model development projects, Envigo supports you with a team of expert surgeons, veterinarians, and scientists who collaborate with you from initial inquiry through to completion. Through our specialized model development services and in-house expertise, we strive to develop bespoke models and novel techniques that achieve your experimental goals.

Whether you are looking for routine infusion catheter implantation or complex, customer-specific model development projects, Envigo supports you with a team of expert surgeons, veterinarians, and scientists who collaborate with you from initial inquiry through to completion.

A majority of our surgical work is conducted in rodent models, large animals, dogs, pigs (both minipigs and conventional pigs), sheep, and primates but our experience also includes rabbit and non-standard models as well.

Our Surgical Services include the following:

  • Experienced surgical study directors and pathologists
  • GLP facilities for surgical projects
  • Customer-specific and novel surgical model development
  • Imaging capabilities include endoscopy, ultrasonography and radiography
  • Routine infusion and telemetry models
  • Left ventricular pressure (LVP) and epicardial lead placement
  • Major and minor surgical procedures
  • Medical devices
  • Wound healing studies
  • Orthopedic models
  • Anesthetized dosing and sampling techniques
  • Anesthetic safety evaluation
  • Surgically prepared disease models and management
  • Full-service laboratory facilities available to support surgical studies and visiting surgeons
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Surgical Animal Models

Price on request

With a seemingly infinite number of options for developing a surgical model, where do you begin? Choosing the right model is critical to getting the most out of your surgical exploration and you need a partner who not only has vast surgical expertise, but a focus on you and meeting your specific objectives. Whether you are... Show more »

With a seemingly infinite number of options for developing a surgical model, where do you begin? Choosing the right model is critical to getting the most out of your surgical exploration and you need a partner who not only has vast surgical expertise, but a focus on you and meeting your specific objectives. Whether you are looking for routine infusion catheter implantation or complex, customer-specific model development projects, Envigo supports you with a team of expert surgeons, veterinarians, and scientists who collaborate with you from initial inquiry through to completion. Through our specialized model development services and in-house expertise, we strive to develop bespoke models and novel techniques that achieve your experimental goals.

A majority of our surgical work is conducted in rodent models, large animals, dogs, pigs (both minipigs and conventional pigs), sheep, and primates but our experience also includes rabbit and non-standard models as well.

Our Surgical Services include the following:

  • Experienced surgical study directors and pathologists
  • GLP facilities for surgical projects
  • Customer-specific and novel surgical model development
  • Imaging capabilities include endoscopy, ultrasonography and radiography
  • Routine infusion and telemetry models
  • Left ventricular pressure (LVP) and epicardial lead placement
  • Major and minor surgical procedures
  • Medical devices
  • Wound healing studies
  • Orthopedic models
  • Anesthetized dosing and sampling techniques
  • Anesthetic safety evaluation
  • Surgically prepared disease models and management
  • Full-service laboratory facilities available to support surgical studies and visiting surgeons
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Environmental Science

Price on request

The environmental risk profile of your chemical decides the fate of your product in different regions of the globe. When you need to respond to the regulatory authorities, be assured that Envigo has more than 20 years of experience in the fields of environmental fate and ecotoxicology in both veterinary medicines and crop... Show more »

The environmental risk profile of your chemical decides the fate of your product in different regions of the globe. When you need to respond to the regulatory authorities, be assured that Envigo has more than 20 years of experience in the fields of environmental fate and ecotoxicology in both veterinary medicines and crop protection products anywhere in the world. We also offer our drug development customers management and consultancy in strategic program design for worldwide registration and environmental modeling. Our experts can assist you in the preparation of environmental evaluations and negotiations with the relevant authorities, no matter where you market your products.

Our Environmental Risk Assessment testing services include:

  • Strategic program design for worldwide registration
  • Environmental modelling
  • Close scientific monitoring of testing programs and interpretation of findings
  • Advice on need for higher tier studies
  • Problem solving and trouble-shooting
  • Expert independent review of study reports
  • Preparation of the environmental risk assessments
  • Support for customers in discussions with regulators
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Carcinogenicity/Tumorigenicity Testing

Price on request

You need a reliable and responsive partner in your CRO – one that has the skills and flexibility to manage your challenging requirements and timelines. That means you are looking for a track record of quality and commitment. Envigo has more than 30 years of experience in carcinogenicity studies. We have carried out more than 500... Show more »

You need a reliable and responsive partner in your CRO – one that has the skills and flexibility to manage your challenging requirements and timelines. That means you are looking for a track record of quality and commitment. Envigo has more than 30 years of experience in carcinogenicity studies. We have carried out more than 500 studies in the last 10 years alone. As our drug development customer, you enjoy full access to our substantial scientific and technical resources and expertise to deliver high quality, regulatory-compliant carcinogenicity studies when you need them, how you need them.

Our Testing Services:

  • Individually ventilated cages option
  • Oral, dietary, inhalation, dermal and subcutaneous routes
  • Preliminary study development
  • Mode of action analysis
  • Pathology
  • Statistical analysis
  • Regulatory advice
  • Short term mouse models, Tg.rasH2 and P53+/-
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DART Studies

Developmental and Reproductive Toxicology Studies
Price on request

You need to know in Phase I if your promising drug candidate may have any harmful effect on human reproduction or development. The answer could ultimately make the difference between approval, approval with warnings, or no approval at all. That calls for experience across the range of human reproduction and development, as well as... Show more »

You need to know in Phase I if your promising drug candidate may have any harmful effect on human reproduction or development. The answer could ultimately make the difference between approval, approval with warnings, or no approval at all. That calls for experience across the range of human reproduction and development, as well as an understanding of the possibilities along all routes of administration and pharmacokinetics of your chemical compound.

Enter Envigo. We have more than 40 years of experience in the field of reprotoxicology and a huge breadth of experience with both traditional pharmaceuticals and biologicals. We offer our drug development customers a full comprehensive package of reprotoxicology studies for registration and market authorization. We also offer consultancy services in reproductive studies and reproductive pathology. All in our laboratories which are fully AAALAC accredited.

Our Reproductive Toxicology services include:

  • Study designs for pharmaceuticals
  • Dosing by all conventional routes
  • Extensive, proven behavioral testing
  • Fetal pathology including Wilson’s sectioning and microdissection techniques, staining for bone and cartilage * Computer-assisted sperm assessment (CASA)
  • Specialist pathology of male and female reproductive organs
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Juvenile Toxicology

Price on request

You are initiating a toxicology and safety assessment program for your product and need to conduct a juvenile toxicity study. Where do you begin? How do you know when to conduct a general toxicity study versus more complex study designs with target organ and toxicokinetic evaluations? Envigo is here for you. Our testing... Show more »

You are initiating a toxicology and safety assessment program for your product and need to conduct a juvenile toxicity study. Where do you begin? How do you know when to conduct a general toxicity study versus more complex study designs with target organ and toxicokinetic evaluations? Envigo is here for you. Our testing facilities have the requisite expertise, training and experience to design, conduct, interpret and report juvenile toxicity studies that will meet your specific objectives and regulatory agencies requirements.

At Envigo we offer the following expertise and capabilities for your study:

  • Selection of a model: Typically toxicity studies are performed on the Sprague Dawley rat, although Envigo can adapt the study for mice, rabbits, minipigs, dogs, or cynomolgus monkeys
  • Selection of an appropriate age range for test animals based on the intended pediatric population
  • Selection of dose levels based on regulatory requirements
  • Selection of route of administration
  • Selection of sample size and logistical planning
  • Laboratory technical expertise including cross fostering litters, toxicokinetics, hematology and clinical chemistry blood sampling techniques, immunological/behavioral/reproductive assessments, and specialized necropsy techniques
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Inhalation Toxicology

Price on request

Toxicity testing of your product through an inhaled route of administration can be one of the most challenging studies you will face. Whether you have a pharmaceutical, crop protection, or industrial chemical product, the knowledge you can gain from inhalation studies can be priceless, but you need a reliable ally who knows the... Show more »

Toxicity testing of your product through an inhaled route of administration can be one of the most challenging studies you will face. Whether you have a pharmaceutical, crop protection, or industrial chemical product, the knowledge you can gain from inhalation studies can be priceless, but you need a reliable ally who knows the most successful ways to conduct respiratory safety assessment studies.

With fully integrated facilities in the UK and US, Envigo offers the largest and most experienced inhalation contract capability globally. As a result, transfer of programs, individual studies, or staff is a simple process that enables you to have a significantly larger global resource. Our 50 years of experience has enabled us to conduct repeat dose studies across a wide variety of designs, test article classes (NCE and biologics) and species, including hundreds of studies in the past five years alone.

Envigo provides the following Respiratory Safety Assessment services:

  • Routine studies in rats, mice, hamsters, rabbits, guinea pigs, dogs, macaques, minipigs and occasional work with a variety of less common species
  • Inhalation delivery for general and reproductive toxicology, safety pharmacology and micronucleus studies
  • Cardiovascular and respiratory models using telemetered animals and external (large animal jackets and small animal restraint tube or chamber) plethysmography
  • In-house developed minimal restraint methods for inhalation exposure in dogs and primates
  • Intra-tracheal delivery in rats and large animals
  • Rodent and rabbit snout only exposure using directed flow or flow through systems
  • Whole body exposure of rodents, rabbits, dogs, and minipigs
  • Oropharyngeal delivery in dogs and primates
  • Clinical delivery platform modification to permit use in non-clinical studies
  • Delivery of powders, liquids vapors and gasses by commercially available and in-house designed generation systems
  • Aerosol concentration monitoring including real-time determinations of concentration and particle size
  • Inhalation Engineering Services support of in-house and sponsor inhalation laboratories with design and manufacture of inhalation equipment and exposure systems
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Infusion Toxicology

Price on request

Test substance administration via the infusion route requires a specialized team that understands your formulation and can partner with you to develop the optimal study design. Our team of dedicated toxicologists, scientists and technical staff has many years of experience with infusion administration, and you can be confident... Show more »

Test substance administration via the infusion route requires a specialized team that understands your formulation and can partner with you to develop the optimal study design. Our team of dedicated toxicologists, scientists and technical staff has many years of experience with infusion administration, and you can be confident that your program will be conducted with the utmost skill and attention to detail, from project planning through to reporting.

Intravenous infusion delivery in all the major preclinical species is routine in our laboratories, ranging from several minutes per occasion to 24 hours per day continuous delivery. If you are looking for creative solutions to your complex programs, Envigo is here to support you.

Our Infusion Toxicology services include the following:

  • Experienced infusion toxicologists, pharmacists, technical staff and pathologists
  • Ambulatory, syringe, volumetric and implantable infusion pumps
  • Surgical and non-surgical models
  • Ambulatory or restrained delivery available in rodents, dogs, primates, minipigs and sheep
  • Intravenous, intrathecal, subcutaneous and other specialized infusion sites
  • Hemocompatibility studies (hemolytic potential and plasma compatibility)
  • Compatibility of formulation with administration equipment
  • Development of novel infusion methods to meet customer needs
  • Anesthetic safety evaluation
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In vitro Genotoxicity Testing

Price on request

First do no harm. It is not enough that your drug is effective – it must be safe. Envigo has been providing genetic toxicology services to our drug development customers for more than 30 years under our dedicated team of scientists with vast combined experience in all aspects of genetic toxicology. Whether you are a small,... Show more »

First do no harm. It is not enough that your drug is effective – it must be safe. Envigo has been providing genetic toxicology services to our drug development customers for more than 30 years under our dedicated team of scientists with vast combined experience in all aspects of genetic toxicology. Whether you are a small, exciting biotech startup or a large multinational pharmaceutical corporation, we offer expertise to help you ensure that the products you are developing are doing all the good you know they can.

  • Ames Test
  • Mouse Lymphoma Assay
  • Chromosome aberration test
  • In Vitro Micronucleus Test
  • In Vivo Micronucleus Test
  • Unscheduled DNA Synthesis Test (in vitro and in vivo)
  • Comet Assay (in vitro and in vivo)
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Safety Pharmacology

Price on request

You need a wealth of experience from your CRO. That experience must encompass the use of multiple species for regulatory safety pharmacology studies. It also needs to include efficacy evaluation of a wide variety of test materials. You’ve come to the right place. Envigo has experience across our entire organization at your... Show more »

You need a wealth of experience from your CRO. That experience must encompass the use of multiple species for regulatory safety pharmacology studies. It also needs to include efficacy evaluation of a wide variety of test materials. You’ve come to the right place. Envigo has experience across our entire organization at your disposal to support in-life phases of your study and a wide diversity of bioassay endpoints.

In fact, we have a long heritage in safety pharmacology. With more than 25 years’ experience, we are specialists in the performance of high quality in vitro and in vivo studies conducted to the highest ethical standards and tailored to meet regulatory and scientifically relevant endpoints.

Our Safety Pharmacology testing services include:

  • Cardiovascular
  • Respiratory assessment
  • Central nervous system
  • Electrophysiology
  • Follow-on studies
  • Supplemental studies
  • Efficacy
  • Bespoke study designs
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In vitro Drug Safety Evaluation

Price on request

Whether you are developing products for the chemical, agrochemical, or pharmaceutical industries, you cannot compromise the assurance of safety. At Envigo, we take safety very seriously. As the market leaders in in vitro Safety Assessment services, we have developed more than 30 in vitro assays over the past 30+ years. From safety... Show more »

Whether you are developing products for the chemical, agrochemical, or pharmaceutical industries, you cannot compromise the assurance of safety. At Envigo, we take safety very seriously. As the market leaders in in vitro Safety Assessment services, we have developed more than 30 in vitro assays over the past 30+ years. From safety assessment for screening to hazard labeling and regulatory submission, you have access to four dedicated in vitro centers of expertise based in Europe.

Our in vitro Safety Assessment services include the following:

  • Genotoxicity testing
  • Skin irritancy/corrosivity testing
  • Eye irritancy/corrosivity testing
  • Skin sensitization
  • Cytotoxicity testing
  • In vitro carcinogenicity
  • Endocrine disrupter screening
  • Vaccine safety/efficacy evaluation
  • Antimicrobial development/efficacy
  • Microbial Pest Control Agent safety assessment/quality control
  • Bacteriology services for clinical trials
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Immunoassay Development

Price on request

Envigo provides a full range of immune assessment techniques to help drug developers reliably evaluate the pharmacology and safety profile of small and large molecule drug candidates to satisfy regulatory requirements.

Envigo is experienced at developing and validating customized, biologically-relevant immune assessment assays... Show more »

Envigo provides a full range of immune assessment techniques to help drug developers reliably evaluate the pharmacology and safety profile of small and large molecule drug candidates to satisfy regulatory requirements.

Envigo is experienced at developing and validating customized, biologically-relevant immune assessment assays using an appropriate range of tests, assay types and models.

Techniques available include:
+ Immunoassay studies incorporate ligand binding assays (e.g. ELISA, MSD) for biomarker assessment
+ T-cell-dependent antibody response (TDAR) assay
+ Singleplex ligand binding assays: ELISA, EIA, IRMA
+ Multiplex assays: MSD, Luminex
+ High-throughput, low-volume sample assays e.g. Gyrolab
+ Hybridization assays
+ Flow cytometry studies incorporate in vitro pyrogen test (IPT), RO and cell-based assays
+ Cell-based bioassays to measure ex-vivo PD effects or immunogenicity
+ Customized, in vitro, cell-based assays
+ Enzyme assays
+ ELISpot assays

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Bioanalytical Analysis LC/MS/MS

Price on request

Envigo supports your small or large molecule program with an integrated team of drug development specialists to understand your compound and ensure the best strategy is applied.

Envigo develops and validates >130 assays, and processes over 150,000 bioanalytical samples per year, supporting discovery through
to clinical... Show more »

Envigo supports your small or large molecule program with an integrated team of drug development specialists to understand your compound and ensure the best strategy is applied.

Envigo develops and validates >130 assays, and processes over 150,000 bioanalytical samples per year, supporting discovery through
to clinical development for small and large molecules across multiple matrices and instrument platforms.

Capabilities include:
+ Rapid method development, transfer and validation support
+ Reliable GLP/GCP-validated LC-MS/MS methods, immunoassays and flow cytometry assays
+ Non-GLP discovery bioanalysis and method feasibility support
+ Expertise in multiple assays including: TK/PK, PD, safety, bioequivalence, DDI and bioavailability
+ Experience in peptide, protein, oligonucleotide and antibody-drug conjugates (ADC) by LC-MS/MS
+ Full support with data interpretation and statistical analysis
+ Harmonized global bioanalytical support across the United States, United Kingdom and Europe

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

Understanding the pharmacokinetics of your compound is critical to drug development, and generating early reliable pharmacokinetic data can significantly impact the outcomes of your research & development project. At Envigo, we strive to help you quickly make the most out of your drug metabolism and pharmacokinetic data. As your... Show more »

Understanding the pharmacokinetics of your compound is critical to drug development, and generating early reliable pharmacokinetic data can significantly impact the outcomes of your research & development project. At Envigo, we strive to help you quickly make the most out of your drug metabolism and pharmacokinetic data. As your drug development ally, we secure the potential for your product by defining product clearance and prediction to human, helping you choose the most appropriate toxicology species, enhancing your understanding of the link between exposure and safety, and characterizing the correlation between pharmacokinetics and pharmacodynamics (PK/PD). Our team of discovery pharmacokinetic study directors is committed to providing you with unmatched customer service, including a single point of control who works closely with you from study initiation to data generation.

Our Core Services:

  • Abbreviated PK design
  • Full PK
  • Blood-brain barrier transfer
  • Absorption studies
  • Tissue distribution
  • PK/PD
  • Formulation comparison
  • Clearance designs
  • Food effect
  • Toxicokinetics
  • Microsampling
  • Dedicated or rental non-rodent (dog, primate and minipig) colonies
  • Cassette dosing
  • Integrated bioanalytical support
  • Automated data transfer
  • Template reports (standard or bespoke).
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Large Molecule Bioanalysis

Price on request

Whether your product is in discovery, pre-clinical, or clinical development, you need to develop a comprehensive understanding of how your potential biologic drug will work. You depend on a partner who not only has the breadth of bioanalytical services, but a dedication to offering you guidance and seamless communication as you... Show more »

Whether your product is in discovery, pre-clinical, or clinical development, you need to develop a comprehensive understanding of how your potential biologic drug will work. You depend on a partner who not only has the breadth of bioanalytical services, but a dedication to offering you guidance and seamless communication as you proceed through development. At Envigo, we apply our 20+ years experience in bioanalysis, biomarkers, and clinical services solely to your success. With a comprehensive team of experts, we support projects in any of the following areas:

  • Immunoassay, immunogenicity, and immunophenotyping
  • Cell biology
  • Flow cytometry and cell-based assays
  • Clinical pathology
  • PK/TK
  • vivo bioassay
  • in vitro species selection studies

All work is carried out within modern laboratories and the work conducted meets GLP and GCP regulations.

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Small Molecule Bioanalysis

Price on request

Bioanalysis is a pivotal aspect of all drug development whether you are focused on your product’s pharmacodynamics or conducting toxicokinetic/pharmacokinetic evaluation. With so much riding on the future of your product, you need a trusted partner who has both a full suite of bioanalytical services and the expertise to ensure... Show more »

Bioanalysis is a pivotal aspect of all drug development whether you are focused on your product’s pharmacodynamics or conducting toxicokinetic/pharmacokinetic evaluation. With so much riding on the future of your product, you need a trusted partner who has both a full suite of bioanalytical services and the expertise to ensure your method development is flawless. With over 35 years experience in the US and Europe, Envigo offers you a full range of analytical support ranging from characterized assays to meet pre-GLP lead optimization needs, to feasibility, method development, method transfer, method validation and sample analysis.

Our Small Molecule Bioanalytical services include the following:

  • LC-MS/MS bioanalysis of small molecules
  • Bioanalytical support form Discovery to Phase III/IV
  • Small molecule pharmacodynamic (biomarker) bioanalysis
  • LC-MS/MS bioanalysis of peptides
  • Non-GLP PK screening and PK/PD lead optimization
  • Proof of Concept
  • Toxicokinetic studies
  • Veterinary drug development analyses
  • Tissue expertise
  • Clinical studies (especially fast turnaround Phase I SAD & MAD)
  • Microsomal blood/plasma partitioning in vitro metabolism study support (e.g. Caco-2 and plasma protein binding)
  • in vivo DMPK support such as PK, ADME and mass balance studies
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Plasma Protein Binding

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
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In vivo Protein Binding Assays

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
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In vitro Metabolic Stability Assays

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
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Caco-2 Cell Permeability Assay

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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In vivo Drug Efficacy Testing

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
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In vitro Cardiotoxicity Screening

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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In vitro Toxicity Testing

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Mutagenicity Testing

Price on request

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in... Show more »

Envigo’s Exploratory Testing Services include the following:

  • Screening versions of the Ames Test, in vitro micronucleus, mouse lymphoma assay, in vitro mammalian chromosome aberration test in human lymphocytes
  • in vitro skin and eye irritation/sensitization assays (BCOP, Episkin)
  • Cardiotoxicity liability testing in cardiac ion channels, including Herg assay
  • Biomarker assay development and qualification - safety and efficacy markers
  • Kinetics in human and animal hepatocytes
  • Single and repeat dose in vivo non-clinical pharmacokinetics
  • Bespoke early repeat dose toxicology studies up to two week duration in suitable species
  • Membrane permeability (CaCO-2 cells)
  • Metabolic stability in human liver microsomes or hepatocytes
  • CYP inhibition
  • Protein binding in human plasma
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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In vitro ADME/DMPK Studies

Price on request

You need to know how your drug candidate behaves in all kinds of patients and in all kinds of formulations. At Envigo, we have been analyzing the pharmacologic activity of our customers’ molecules and compounds for decades.

Drawing on our scientists’ expertise in drug candidate profiling, we have devised numerous in-depth... Show more »

You need to know how your drug candidate behaves in all kinds of patients and in all kinds of formulations. At Envigo, we have been analyzing the pharmacologic activity of our customers’ molecules and compounds for decades.

Drawing on our scientists’ expertise in drug candidate profiling, we have devised numerous in-depth assays to provide you with important information on the absorption, distribution, metabolism and excretion (ADME) of your candidate molecules. Our experience and dedicated state-of-the-art facilities mean that we can handle very small quantities (sub-milligram) of starting material to give you all the information you need about the ADME characteristics of your molecule and do it in highly cost-effective turnaround times.

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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Chemistry, Manufacturing and Controls (CMC)

Price on request

Analytical CMC Support:

What is at the core of every successful pharmaceutical development program? Accurate characterization, low-risk method development, and assured product stability. You need a trusted partner with wide-ranging experience in analytics, product development, regulatory requirements, and validation, and an... Show more »

Analytical CMC Support:

What is at the core of every successful pharmaceutical development program? Accurate characterization, low-risk method development, and assured product stability. You need a trusted partner with wide-ranging experience in analytics, product development, regulatory requirements, and validation, and an ally who can meet all your CMC needs.

At Envigo, our CMC analysts are experienced in developing analytical techniques that are qualification-ready and suitable for GMP operations. With decades of experience in operating a GMP quality environment, you can feel confident in Envigo’s qualification and validation expertise at all phases of your product’s development.

Envigo CMC services include a wide range of non-GXP biopharmaceutical development studies, including the following:

  • Analytical Development
  • Protein Characterization
  • Antibody Characterization
  • Developability
  • Formulation Development
  • Forced Degradation/Stress Testing
  • Biologics Therapeutic Characterization/Validation

We offer testing services for:

  • Biopharmaceutical Analysis including q-PCR
  • Vaccines
  • Monoclonal Antibodies
  • Peptides and Proteins
  • Gene Therapy
  • Specialized Inhalation Performance Testing
  • Batch Release and Testing
  • Stability Testing
  • Microbiology
  • Stress Testing
  • Method Transfer
  • Pharmacopeia Testing
  • Method Development/Validation
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Biomarker Analysis

Price on request

Our Biomarker Testing Services:

  • Assessment of drug safety and efficacy Indicator of drug response
  • Selection of lead candidates for subsequent clinical evaluation
  • Confirmation of pharmacological activity and optimization of dose regimens
  • Biomarker utilization
  • Aid volunteer/patient inclusion in clinical studies... Show more »

Our Biomarker Testing Services:

  • Assessment of drug safety and efficacy Indicator of drug response
  • Selection of lead candidates for subsequent clinical evaluation
  • Confirmation of pharmacological activity and optimization of dose regimens
  • Biomarker utilization
  • Aid volunteer/patient inclusion in clinical studies
  • Aid clinical decision making (go/no go) in Phase II Support
  • Phase IV post approval surveillance
  • Patient stratification in clinical trials
  • Three tier immunogenicity screening and confirmation

Our full range of biomarkers analysis tools:

  • Flow cytometry (Sysmex) for inflammatory cell differentiation
  • Cytokines – multiplex technology
  • Transcription profiling
  • Full histo-pathology support (including IHC and special staining)
  • Hematology
  • Full service bioanalytical support PK/PD modeling
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411) Flow cytometry

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Custom Cardiovascular Animal Models

Price on request

Our cardiovascular services:

  • Heamodynamics and electrocardiology (rodent and large animal)
  • Echocardiography in development for rodent and large animals
  • Ion channel electrophysiology

Our cardiovascular services:

  • Heamodynamics and electrocardiology (rodent and large animal)
  • Echocardiography in development for rodent and large animals
  • Ion channel electrophysiology
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411) Rodents

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Wound Healing Animal Models

Price on request

Our anti-infective services:

  • Wound healing (+/- MRSA infection) (rodent, rabbit, pig)
  • Influenza - tissue burden and biomarker endpoints
  • Host resistance

Our anti-infective services:

  • Wound healing (+/- MRSA infection) (rodent, rabbit, pig)
  • Influenza - tissue burden and biomarker endpoints
  • Host resistance
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411) Rabbit Pig Rodents

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Gastrointestinal Disease Animal Models

Price on request

Our gastrointestinal services:

  • Emesis / anti-emesis (ferret)
  • GI motility (rodent; large animal planned for development )
  • IBD models (rodent; primate planned for development)
  • Feeding / dietary models (rodent)

Our gastrointestinal services:

  • Emesis / anti-emesis (ferret)
  • GI motility (rodent; large animal planned for development )
  • IBD models (rodent; primate planned for development)
  • Feeding / dietary models (rodent)
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411) Ferret Mouse Rodents Non-human primates (NHP) Show 6 more tags Show less

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Pulmonary Inflammation Animal Models

Price on request

Our respiratory inflammation services:

  • The house dust mite model of chronic allergic inflammation (mouse)
  • Antigen-induced pulmonary inflammation (Ovalbumin sensitized brown Norway rat mouse or guinea pig)
  • LPS induced non-allergic pulmonary inflammation (mouse, rat, guinea pig; also primate in our US facility)
    *... Show more »

Our respiratory inflammation services:

  • The house dust mite model of chronic allergic inflammation (mouse)
  • Antigen-induced pulmonary inflammation (Ovalbumin sensitized brown Norway rat mouse or guinea pig)
  • LPS induced non-allergic pulmonary inflammation (mouse, rat, guinea pig; also primate in our US facility)
  • Cigarette smoke-induced pulmonary inflammation (mouse)
  • Bleomycin-induced lung fibrosis (rat)
  • Bronchoconstriction/ bronchodilator studies in conscious and anesthetized animals (rodent, guinea pig and dog)
  • All standard routes of delivery available
  • Inhalation delivery optional
    • Extensive capabilities and experience
    • Aerosol and dry powder
    • Unique in-house developed system for dry powder delivery using small amounts of test material.
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411) Guinea pig Mouse Rat Non-human primates (NHP) Show 6 more tags Show less

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Drug Transporter Assays

Price on request

Envigo offers a full range of in vitro assays (basic models) designed to assess the following:

  • Which enzymes and transporters are involved in drug clearance (substrate interactions)
  • The effect(s) of a new chemical entity on important drug metabolizing enzymes such as CYP and UGT (inhibition and induction interactions)
    *... Show more »

Envigo offers a full range of in vitro assays (basic models) designed to assess the following:

  • Which enzymes and transporters are involved in drug clearance (substrate interactions)
  • The effect(s) of a new chemical entity on important drug metabolizing enzymes such as CYP and UGT (inhibition and induction interactions)
  • The effect(s) of a new chemical entity on drug efflux and uptake transporters (inhibition interactions).
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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CYP Induction Assay

Price on request

Envigo offers a full range of in vitro assays (basic models) designed to assess the following:

  • Which enzymes and transporters are involved in drug clearance (substrate interactions)
  • The effect(s) of a new chemical entity on important drug metabolizing enzymes such as CYP and UGT (inhibition and induction interactions)
    *... Show more »

Envigo offers a full range of in vitro assays (basic models) designed to assess the following:

  • Which enzymes and transporters are involved in drug clearance (substrate interactions)
  • The effect(s) of a new chemical entity on important drug metabolizing enzymes such as CYP and UGT (inhibition and induction interactions)
  • The effect(s) of a new chemical entity on drug efflux and uptake transporters (inhibition interactions).
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LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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CYP Inhibition Assay

Price on request

Envigo offers a full range of in vitro assays (basic models) designed to assess the following:

  • Which enzymes and transporters are involved in drug clearance (substrate interactions)
  • The effect(s) of a new chemical entity on important drug metabolizing enzymes such as CYP and UGT (inhibition and induction interactions)
    *... Show more »

Envigo offers a full range of in vitro assays (basic models) designed to assess the following:

  • Which enzymes and transporters are involved in drug clearance (substrate interactions)
  • The effect(s) of a new chemical entity on important drug metabolizing enzymes such as CYP and UGT (inhibition and induction interactions)
  • The effect(s) of a new chemical entity on drug efflux and uptake transporters (inhibition interactions).
Show less
LightCycler Cobas systems (4800 or 6800/8800, b 221, s 201, or u 411)

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Clinical Research

Price on request
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Clinical Laboratory Services

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Immunology Animal Models

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Cytometry

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Electron Microscopy

Price on request
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Spectrophotometry

Price on request
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Biomolecular Interaction Analysis

Price on request
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Product Development, Testing, and Packaging

Price on request
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Veterinary Laboratory Services

Price on request
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Immunoassays

Price on request
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Biology

Price on request
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Tissue Embedding

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Toxicology

Price on request
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Vaccines

Price on request
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Infectious Disease Animal Models

Price on request
  • Wound healing (+/- MRSA infection) (rodent, rabbit, pig)
  • Influenza - tissue burden and biomarker endpoints
  • Host resistance
  • Wound healing (+/- MRSA infection) (rodent, rabbit, pig)
  • Influenza - tissue burden and biomarker endpoints
  • Host resistance
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Rabbit Pig Rodents

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Cardiovascular Animal Models

Price on request
  • Heamodynamics and electrocardiology (rodent and large animal)
  • Echocardiography in development for rodent and large animals
  • Ion channel electrophysiology
  • Heamodynamics and electrocardiology (rodent and large animal)
  • Echocardiography in development for rodent and large animals
  • Ion channel electrophysiology
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Mouse Rat Dog Rodents

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Clinical Trials, Consulting, and Management

Price on request

Envigo’s pharmaceutical consulting and program management service has the scientific and regulatory experience to develop customized non-clinical
development programs that meet the unique challenges of your therapeutic, navigating its unique needs as it journeys from discovery, through non-clinical safety assessment, into clinical... Show more »

Envigo’s pharmaceutical consulting and program management service has the scientific and regulatory experience to develop customized non-clinical
development programs that meet the unique challenges of your therapeutic, navigating its unique needs as it journeys from discovery, through non-clinical safety assessment, into clinical trials and onto marketing authorization.

Regardless of whether you seek to generate initial data sets, out-license your compound or take it all the way to market, our team’s aim is to ensure value by:
+ Understanding the data to predict which studies are critical to success – and equally important those that are not – saving you vital budget and time
+ Designing appropriate, optimal programs to get you the data you need at each milestone
+ Working with you at every stage to ensure you avoid the common pitfalls and maximize your investment with clear and insightful communication throughout
+ Ensuring your data sets are robust and presented to key stakeholders or regulatory authorities in a manner that maximizes your opportunity for success

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Biomarkers

Price on request
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Clinical and Anatomic Pathology

Price on request
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Animal Models of Disease

Price on request

Search below to see the diversity, strength and depth of our offerings, including the areas of respiration and inflammation.

Our respiratory inflammation services:

  • The house dust mite model of chronic allergic inflammation (mouse)
  • Antigen-induced pulmonary inflammation (ovalbumin sensitized brown Norway rat mouse or... Show more »

Search below to see the diversity, strength and depth of our offerings, including the areas of respiration and inflammation.

Our respiratory inflammation services:

  • The house dust mite model of chronic allergic inflammation (mouse)
  • Antigen-induced pulmonary inflammation (ovalbumin sensitized brown Norway rat mouse or guinea pig)
  • LPS induced non-allergic pulmonary inflammation (mouse, rat, guinea pig; also primate in our US facility)
  • Cigarette smoke-induced pulmonary inflammation (mouse)
  • Bleomycin-induced lung fibrosis (rat)
  • Bronchoconstriction/ bronchodilator studies in conscious and anesthetized animals (rodent, guinea pig and dog)

All standard routes of delivery available
Inhalation delivery optional
Extensive capabilities and experience
Aerosol and dry powder
Unique in-house developed system for dry powder delivery using small amounts of test material

Our gastrointestinal services:

  • Emesis / anti-emesis (ferret)
  • GI motility (rodent; large animal planned for development)
  • IBD models (rodent; primate planned for development)
  • Feeding / dietary models (rodent)

Our anti-infective services:

  • Wound healing (+/- MRSA infection) (rodent, rabbit, pig)
  • Influenza - tissue burden and biomarker endpoints
  • Host resistance

Our cardiovascular services:

  • Heamodynamics and electrocardiology (rodent and large animal)
  • Echocardiography in development for rodent and large animals
  • Ion channel electrophysiology
Show less
Rabbit Guinea pig Ferret Mouse Pig Rat Dog Non-human primates (NHP) Minipig Show 9 more tags Show less

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Epidemiology, Healthcare, and Post-Authorization Studies

Price on request
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Veterinary Research & Diagnostics

Price on request
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Protein Services

Price on request
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Regulatory Affairs Services

Price on request

Envigo’s regulatory affairs team is equipped with the knowledge and skills to provide your company with a comprehensive understanding of current regulatory guidelines and procedures. Our experienced consultancy group provides practical advice and support to our drug development customers in moving products from early concept to... Show more »

Envigo’s regulatory affairs team is equipped with the knowledge and skills to provide your company with a comprehensive understanding of current regulatory guidelines and procedures. Our experienced consultancy group provides practical advice and support to our drug development customers in moving products from early concept to marketing authorization. With a proven track record of success across the world, we can help you throughout the entire lifecycle of your product to achieve your goals in a fast, low risk and efficient manner. With offices in the UK, US and Japan, we provide regulatory services throughout the International Conference on Harmonization (ICH) regions, and we can offer a global regulatory service through our affiliations in other non-ICH regions.

Services to support pre-clinical, clinical and post marketing phases:
+ Preparation of marketing authorization applications, clinical trial authorization applications and INDs
+ Preparation of requests for scientific advice from FDA, EMA and EU national authorities
+ Support for customers in Regulatory Authority meetings; advice on regulatory strategy; due diligence on existing data packages
+ Preparation of orphan drug designations in EU and US, pediatric investigation plans and drug master files
+ Advice on regulatory requirements for individual studies, taking into account product type and therapeutic class, and review and interpretation of study data
+ Regulatory support for the development of devices, drug/device combinations and borderline products.
+ Clinical trial legal representative services for non-EU companies and US Agent services for non-US companies

We can maximize the success of your product by assisting you with non-clinical and clinical support:
+ Due diligence
+ Agency and working party meetings e.g., ITF meeting
+ Scientific advice / protocol assistance
+ CTA / IND applications and maintenance
+ Pediatric investigation plans
+ Orphan drug designation
+ Fast track applications / special protocol assistance (marketing authorization applications)
+ Pre submission meetings
+ MAA/NDA/BLA preparation and filing
+ eCTD and NeeS submissions
+ Drug master files
+ Responses to agency questions (post marketing approval)
+ License variations
+ Renewals
+ Line extensions
+ Submissions to additional countries
+ Product maintenance

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Cell-Based Assays

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Discovery Pathology

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Animal Models and Studies

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Guinea pig Ferret Mouse Pig Rat Dog Rodents Non-human primates (NHP) Show 8 more tags Show less

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Liquid Chromatography (LC)

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Cell Invasion & Migration Assays

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Histological Staining

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Microscopy

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Protein Expression Visualization

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Animal Model in vivo Analyses

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Guinea pig Ferret Mouse Pig Rat Dog Rodents Non-human primates (NHP) Show 8 more tags Show less

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Optical Microscopy

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Drug Discovery

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Cytotoxicity Assays

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Analytical Chemistry Services

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Nucleic Acid Services

Price on request
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In vitro Disease Models

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Product Quality Control

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DNA Services

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Pharmacology & Toxicology

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Spectroscopy

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Bioanalytical Assays

Price on request

Envigo supports your small or large molecule program with an integrated team of drug development specialists to understand your compound and ensure the best strategy is applied.

Envigo develops and validates >130 assays, and processes over 150,000 bioanalytical samples per year, supporting discovery through
to clinical... Show more »

Envigo supports your small or large molecule program with an integrated team of drug development specialists to understand your compound and ensure the best strategy is applied.

Envigo develops and validates >130 assays, and processes over 150,000 bioanalytical samples per year, supporting discovery through
to clinical development for small and large molecules across multiple matrices and instrument platforms.

Capabilities include:
+ Rapid method development, transfer and validation support
+ Reliable GLP/GCP-validated LC-MS/MS methods, immunoassays and flow cytometry assays
+ Non-GLP discovery bioanalysis and method feasibility support
+ Expertise in multiple assays including: TK/PK, PD, safety, bioequivalence, DDI and bioavailability
+ Experience in peptide, protein, oligonucleotide and antibody-drug conjugates (ADC) by LC-MS/MS
+ Full support with data interpretation and statistical analysis
+ Harmonized global bioanalytical support across the United States, United Kingdom and Europe

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Chemistry and Materials

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Tissue Processing

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Separation/Purification Services

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Biochemistry & Molecular Biology

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Inflammation Animal Models

Price on request

Our respiratory inflammation services:

  • The house dust mite model of chronic allergic inflammation (mouse)
  • Antigen-induced pulmonary inflammation (ovalbumin sensitized brown Norway rat mouse or guinea pig)
  • LPS induced non-allergic pulmonary inflammation (mouse, rat, guinea pig; also primate in our US facility)
    *... Show more »

Our respiratory inflammation services:

  • The house dust mite model of chronic allergic inflammation (mouse)
  • Antigen-induced pulmonary inflammation (ovalbumin sensitized brown Norway rat mouse or guinea pig)
  • LPS induced non-allergic pulmonary inflammation (mouse, rat, guinea pig; also primate in our US facility)
  • Cigarette smoke-induced pulmonary inflammation (mouse)
  • Bleomycin-induced lung fibrosis (rat)
  • Bronchoconstriction/ bronchodilator studies in conscious and anesthetized animals (rodent, guinea pig and dog)

All standard routes of delivery available

  • Inhalation delivery optional
  • Extensive capabilities and experience
  • Aerosol and dry powder
  • Unique in-house developed system for dry powder delivery using small amounts of test material
Show less
Guinea pig Mouse Rat Dog Non-human primates (NHP)

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Formulation Services

Price on request
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Antibody Services

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Functional & Cell Type Specific Assays

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Cells and Tissues

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Chromatography

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Imaging & Spectroscopy

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Animal Physiology Analyses

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Specialized Cell-Based Assays

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Project Management

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Biospecimens

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Cell Viability & Proliferation Assays

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Drug Discovery & Development

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Bioanalysis

Price on request
  • Small molecules and macromolecules
  • Expert bioanalytical support
  • Method validation to meet FDA guidelines
  • Sample analysis
  • Proven track record of supporting pre-clinical studies and large multi-center clinical programs
  • Fast accurate turn-around of the highest quality
  • Biomarkers
  • Small molecules and macromolecules
  • Expert bioanalytical support
  • Method validation to meet FDA guidelines
  • Sample analysis
  • Proven track record of supporting pre-clinical studies and large multi-center clinical programs
  • Fast accurate turn-around of the highest quality
  • Biomarkers
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Agilent 1200 SCIEX QTRAP 5500 ACQUITY™ UPLC™ Waters Alliance HPLC TOMTEC™, Hamilton® STAR™ Symbiosis™ PRO multiplex LC-MS/MS Singleplex hybridization Show 11 more tags Show less

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Geological Sciences

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PCR

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Gastroenterology Animal Models

Price on request

Our gastrointestinal services:

Emesis / anti-emesis (ferret)
GI motility (rodent; large animal planned for development)
IBD models (rodent; primate planned for development)
Feeding / dietary models (rodent)

Our gastrointestinal services:

Emesis / anti-emesis (ferret)
GI motility (rodent; large animal planned for development)
IBD models (rodent; primate planned for development)
Feeding / dietary models (rodent)

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Ferret Mouse Rat Rodents Non-human primates (NHP)

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Product Testing Services

Price on request

Product Testing Services

Product Testing Services

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Cell Signaling Analyses

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Pharmacology

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Pharmacology Services

Pharmacology Services

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Drug Absorption Studies

Price on request

Drug Absorption Studies Services

Drug Absorption Studies Services

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Product Stability Testing

Price on request

Product Stability Testing Services

Product Stability Testing Services

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In vitro Pharmacology Studies

Price on request

In vitro Pharmacology Studies Services

In vitro Pharmacology Studies Services

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Manufacturing Services

Price on request

Manufacturing Services

Manufacturing Services

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In vivo Pharmacology Studies

Price on request

In vivo Pharmacology Studies Services

In vivo Pharmacology Studies Services

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