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Eurofins Advinus Limited

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Bengaluru, Karnataka, IN

About Eurofins Advinus Limited

Divison of: Eurofins Group

Eurofins Advinus Ltd (formerly Advinus Therapeutics Limited) is a premier R&D services company that supports the discovery and development of compounds for diverse industries including Pharmaceuticals, Biologicals, Nutraceuticals, Cosmetics, Medical Device, Specialty Chemicals and Agrochemicals.

Our... Show more »

Eurofins Advinus Ltd (formerly Advinus Therapeutics Limited) is a premier R&D services company that supports the discovery and development of compounds for diverse industries including Pharmaceuticals, Biologicals, Nutraceuticals, Cosmetics, Medical Device, Specialty Chemicals and Agrochemicals.

Our facility has over 25 years of GLP experience in conducting regulatory studies in compliance with global regulations for supporting clinical trials and registration of substances and products globally. Eurofins Advinus has been inspected twice by the USFDA for GLP studies submitted as part of IND packages. We have submitted 50+ complete IND packages globally. We have also conducted over 60 carcinogenicity studies and ~10,000 regulatory and non-regulatory studies for our global clients.

Our Drug Discovery services include – Discovery chemistry ( Medicinal Chemistry / Synthetic Chemistry / Analytical Chemistry), Discovery Biology ( In Vitro Biology /In Vivo Pharmacology), DMPK/ADMET( In Vitro ADME Assays / In Vivo PK Studies / Discovery Bioanalysis)

We offer end-to-end services in the areas of preclinical toxicology testing, chemical process development, analytical R&D, drug metabolism and pharmacokinetics for IND submission. In addition, the company also offers long term non-clinical toxicology testing, including carcinogenicity studies, in support of pharmaceutical new drug applications (NDA).

We offer comprehensive services to support Agrosciences industry since 1992. These include Phys-chem, Residue, 5 batch, E-Fate and Regulatory Toxicology services to enable registration of its clients’ products globally. The studies are conducted in accordance with regulatory requirements of OECD, USEPA, EMA, ICH, JMAFF, ASTM, Brazilian, Indian CIB and other global guidelines.

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Certifications & Qualifications

AAALAC GLP

Our Services (33)


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In vitro Skin Models

Price on request
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In vitro Exploratory Toxicology Studies

Price on request

Mini Ames
Mini hERG (hERG screening)
Dose range finding studies
Screening CVS function in telemetered dogs

Mini Ames
Mini hERG (hERG screening)
Dose range finding studies
Screening CVS function in telemetered dogs

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Impurity Synthesis

Price on request
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Medical Device Testing

Price on request

Medical Devices Testing (ISO 17025 & GLP)
We offer full scope of testing as per ISO 10993:1 & other regulatory guidelines
· Cytotoxicity
· Genotoxicity test
· Hemocompatibility
· Sub-/acute and sub-/chronic systemic toxicological studies
· Sensitization test
· Irritation test
· Systemic toxicity testing
· Ocular... Show more »

Medical Devices Testing (ISO 17025 & GLP)
We offer full scope of testing as per ISO 10993:1 & other regulatory guidelines
· Cytotoxicity
· Genotoxicity test
· Hemocompatibility
· Sub-/acute and sub-/chronic systemic toxicological studies
· Sensitization test
· Irritation test
· Systemic toxicity testing
· Ocular biocompatibility test
· Implantation test
· Cytotoxicity test of contact lenses

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Cosmetic and Personal Care Product Testing

Price on request

• Episkin – skin irritation test
• Episkin – skin corrosion test

• In vitro skin sensitization
o Direct peptide reactivity assay (DPRA)
o KeratinoSens
o Human cell line activation test (h-CLAT)

• EpiOcular
• The bovine corneal opacity and permeability (BCOP)

• Episkin – skin irritation test
• Episkin – skin corrosion test

• In vitro skin sensitization
o Direct peptide reactivity assay (DPRA)
o KeratinoSens
o Human cell line activation test (h-CLAT)

• EpiOcular
• The bovine corneal opacity and permeability (BCOP)

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Bioanalytical Assays

Price on request

Advinus offers bioanalytical services for novel biologics and biosimilars including regulatory and non-regulatoryin vitro and in vivo studies

Currently Advinus offers:

  • Capability for method development and validation to comply with GLP requirements
  • Validation using commercially-available ELISA kits
  • Capability for... Show more »

Advinus offers bioanalytical services for novel biologics and biosimilars including regulatory and non-regulatoryin vitro and in vivo studies

Currently Advinus offers:

  • Capability for method development and validation to comply with GLP requirements
  • Validation using commercially-available ELISA kits
  • Capability for peptide and protein bioanalysis by ELISA methods
  • Fit-for-purpose bioanalysis for biologicals using ELISA platform.
  • Latest technology for micro-plate reading for ELISA assays (absorbance, fluorescence and luminescence).
  • Immunogenicity/antigen-antibody assays including neutralizing antibody assays
  • Capability for biomarker assays
  • Biomarker identification and quantification
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Toxicology

Price on request

IND Enabling Studies

  • Genotoxicity studies
  • Safety pharmacology (in vivo)
  • Toxicology studies (in vivo)

NDA Enabling Studies

  • Toxicology studies (in vivo)

Impurity

  • Impurity qualification studies for pharmaceuticals (in vivo)
  • Immunotoxicology (in vivo)
  • Routes of... Show more »

IND Enabling Studies

  • Genotoxicity studies
  • Safety pharmacology (in vivo)
  • Toxicology studies (in vivo)

NDA Enabling Studies

  • Toxicology studies (in vivo)

Impurity

  • Impurity qualification studies for pharmaceuticals (in vivo)
  • Immunotoxicology (in vivo)
  • Routes of administration

EpiSkin® Test in vitro Skin Corrosion & Irritation

  • in vitro Skin Irritation (OECD 439)
  • in vitro Skin Corrosion (OECD 431)
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Ames test

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In vivo PK/PD Studies

Price on request

Rodents and non-rodents

  • Rats (multiple strains) : healthy and disease models
  • Mouse (multiple strains) : healthy and disease models
  • Beagle dogs: preferred vendor
  • Various routes of administration
  • Single, multiple and cassette dosing
  • Dose proportionality studies
  • Routes ( urine and feces) of... Show more »

Rodents and non-rodents

  • Rats (multiple strains) : healthy and disease models
  • Mouse (multiple strains) : healthy and disease models
  • Beagle dogs: preferred vendor
  • Various routes of administration
  • Single, multiple and cassette dosing
  • Dose proportionality studies
  • Routes ( urine and feces) of excretion

Tissue exposure kinetics in rodents

  • Exposure kinetics in skin, plasma and other organs (liver, spleen, thymus etc., ) of choice
  • Partitioning into brain (frontal cortex, striatum, hippocampus and cerebellum)
  • Cerebrospinal fluid collection
  • Partitioning into ocular and related parts (vitreous humor, retina and sclera)-rat

Dermal pharmacokinetics in rodents

  • Healthy and disease models
  • Assistance in selection of right animal model

Mechanistic pharmacokinetics models in rodents

  • Chronic bile duct cannulated rats
  • Chronic portal vein cannulated Rats
  • ABT treated mouse and rat pharmacokinetics to delineate involvement of CYP enzymes

PK-PD, modelling and simulations (WinNonlin approach)

  • PK-PD/efficacy correlation – exposure or Cmax based
  • PK modelling and simulations (fit for purpose)
  • Scaling of preclinical PK to predict human PK – allometry approach
  • Prediction of starting and efficacious human doses
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In vivo ADME/DMPK Studies

Price on request
  • Experienced team with holistic Drug Discovery experience to delineate the druggability issues early in the discovery programs
  • Capability to develop fit for purpose ADME and in vivo pharmacokinetic studies to scientifically support client requirements
  • Expertise in developing quantitative LC-MS/MS methods for complex biomarkers in bio-fluids and tissue samples
  • Experienced team with holistic Drug Discovery experience to delineate the druggability issues early in the discovery programs
  • Capability to develop fit for purpose ADME and in vivo pharmacokinetic studies to scientifically support client requirements
  • Expertise in developing quantitative LC-MS/MS methods for complex biomarkers in bio-fluids and tissue samples
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Agrochemical Testing

Price on request

Advinus has expertise in designing and synthesizing libraries of high purity synthetic compounds to support agrochemical discovery programs. Advinus offers this service on Full-Time-Equivalent (FTE) basis

  • Our synthetic chemists design efficient synthetic routes using latest synthetic methodologies to synthesize... Show more »

Advinus has expertise in designing and synthesizing libraries of high purity synthetic compounds to support agrochemical discovery programs. Advinus offers this service on Full-Time-Equivalent (FTE) basis

  • Our synthetic chemists design efficient synthetic routes using latest synthetic methodologies to synthesize compounds
  • We have State-of-the-Art labs equipped with sophisticated instruments to carry out reactions using parallel synthesis approach to generate high purity chemical entities for High Throughput Screening (HTS)
  • Advinus has well-equipped analytical labs to support purification of targets by preparative HPLC and characterization using LC-MS, 1H and 13C NMR
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NMR LC-MS

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Regulatory Affairs Consulting

Price on request

Advinus is offering the regulatory services on the following apart from entire gamut of regulatory studies and are;

  • Development of project plan for the NCE for IND
  • Dossier preparation/IMPD document for regulatory submission
  • Preparation of CTD modules with summary tables as required for submission to FDA
  • SEND... Show more »

Advinus is offering the regulatory services on the following apart from entire gamut of regulatory studies and are;

  • Development of project plan for the NCE for IND
  • Dossier preparation/IMPD document for regulatory submission
  • Preparation of CTD modules with summary tables as required for submission to FDA
  • SEND capability for the studies to submit the data in SEND form to FDA
  • Investigative Brochure (IB) preparation
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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

Advinus offers a wide range of DMPK services to support lead optimization and preclinical development. Advinus capabilities and track record include:

  • Highly qualified scientists trained in premier universities in India and abroad
  • Performed over 500 PK studies, 5000 in vitro studies; supported over 200 Toxicology studies... Show more »

Advinus offers a wide range of DMPK services to support lead optimization and preclinical development. Advinus capabilities and track record include:

  • Highly qualified scientists trained in premier universities in India and abroad
  • Performed over 500 PK studies, 5000 in vitro studies; supported over 200 Toxicology studies for regulated bioanalysis and toxicokinetics
  • Bioanalytical team has developed over 120 validated methods for NCEs, supported over 38 complete IND packages
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Chemistry, Manufacturing and Controls (CMC)

Price on request

Advinus offers a full range of chemistry services for drug development at its Bangalore center spanning gram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. The chemistry services are provided on both fee-for-service (FFS) and full-time equivalent (FTE)... Show more »

Advinus offers a full range of chemistry services for drug development at its Bangalore center spanning gram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. The chemistry services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Advinus clients range from academic institutions to small biotech to big pharma, and also agro chemical companies.

Capabilities include:

  • Kilo-lab and pilot-plant for process development, scale-up and production of drug substance for pre-clinical studies
  • Well-equipped, QP-audited cGMP facility/capabilities to produce NCE in quantities suitable to support up to early clinical development
  • An excellent scientific team of skilled, well-trained and highly experienced synthetic organic chemists, analytical chemists, and chemical engineers to follow a regulatory-driven, phase-appropriate process development strategy to support various stages of CMC
  • Experienced scientists with deep understanding of drug discovery and development to ensure speedy and flawless execution of CMC campaigns in a cost-effective manner

Chemistry Services include:

  • Custom Synthesis
    • Gramto multi-kilo gram scale synthesis (non-GMP & cGMP)
    • Focused libraries for lead generation and lead optimization
    • Scaffolds, building blocks and Intermediates
    • Reference and standard compounds
    • Metabolite and impurity synthesis
    • Stable label compounds (deuterium labelled)
    • Scale up support to DMPK and Tox studies
  • Process Development
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Small Molecule Bioanalysis

Price on request

Advinus’ bioanalytical group specializes in quantitative LC-MS/MS method development, method validation and study sample analysis. Bioanalytical services are routinely provided for compounds in discovery, and in preclinical (toxicology) and clinical development. Fit-for-purpose bioanalytical methods are developed for discovery... Show more »

Advinus’ bioanalytical group specializes in quantitative LC-MS/MS method development, method validation and study sample analysis. Bioanalytical services are routinely provided for compounds in discovery, and in preclinical (toxicology) and clinical development. Fit-for-purpose bioanalytical methods are developed for discovery studies. GLP-compliant bioanalysis using fully validated methods developed are performed for studies conducted for regulatory submission.

The team has extensive expertise in developing sensitive methods for LC-MS/MS, including analysis of multi-analytes, metabolites, pro-drugs, and photo/temperature sensitive and ex-vivo instable compounds. Analytical methods for new chemical entities are routinely established and validated for rodent, non-rodent and human species.

Expert technical staff, advanced test equipment, Watson LIMS system (21 CFR Part 11 compliant), on-site Quality Assurance (QA) and rich experience in the area of bioanalysis enables Advinus to provide clients with timely bioanalytical services for both routine and complex studies.

Our experience and capabilities includes

  • Successful bioanalytical method development and validation of 300 plus compounds.
  • Bioanalytical services to support GLP IND enabling study package for FDA, EMEA, MHRA and other global regulatory submissions, and also for other studies requiring analytical support.
  • Ability to develop and validate bioanalytical methods using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to picogram levels
  • Fit-for-purpose method development for non-GLP bioanalysis
  • Sample processing using precipitation, liquid-liquid extractions and solid-phase extractions
  • Capability for derivatization approaches (e.g. for poorly ionizable compounds) including method development and validation
  • Quantification of analyte / metabolite(s) in biological matrices such as plasma, serum and blood samples in compliance with latest regulatory requirements of USFDA, EMEA, etc.,
  • Experience with developing methods for other matrices such as urine, feces, CSF, bile and various tissue homogenates
  • GLP bioanalysis to support preclinical bioequivalence studies
  • Experience with specialized formulations such as liposomes
  • Capability for bioanalytical quantification of clinical trial samples for analyte and or metabolite(s) for Phase-I through Phase-III trials. Experience in developing bioanalytical method for specialized formulations such as liposomes, plant extracts, nutraceuticals etc.
  • Equipped with Watson LIMS – 21 CFR Part 11 compliant Data Management System for data

Software

  • Watson LIMSTM
  • Phoenix WinNonlin
  • Magellan
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Synthetic Chemistry

Price on request
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Pharmacology & Toxicology

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Agriscience

Price on request
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Regulatory Affairs Services

Price on request
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Agricultural Testing

Price on request
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Bioanalysis

Price on request
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Formulation Services

Price on request
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Cosmetic and Personal Care Product Formulation

Price on request
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Medical Devices & Diagnostics

Price on request
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Chemistry and Materials

Price on request
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Product Development, Testing, and Packaging

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Project Management

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Product Testing Services

Price on request

Consumer Product Testing Services

Consumer Product Testing Services

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In vitro Disease Models

Price on request

In vitro Disease Models Services

In vitro Disease Models Services

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Cells and Tissues

Price on request

Cells and Tissues Services

Cells and Tissues Services

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Sequencing data in FASTQ

Price on request

Biology Services

Biology Services

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Drug Discovery & Development

Price on request

Drug Discovery & Development Services

Drug Discovery & Development Services

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In vitro Toxicity Testing

Price on request

In vitro Toxicity Testing Services

In vitro Toxicity Testing Services

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Pharmacology

Price on request

Pharmacology Services

Pharmacology Services

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