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Frontage Laboratories

7 Orders Completed
Exton, Pennsylvania, US

About Frontage Laboratories

Founded: 2001 Type: Privately Held Size: 201-500 employees

At Frontage the foundation of our business is built on our ability to collaborate with a wide breadth of clients in the pharmaceutical and biopharmaceutical industry. We have relationships with the top pharma companies as well as small start-up organizations. We support generic, innovator and consumer health... Show more »

At Frontage the foundation of our business is built on our ability to collaborate with a wide breadth of clients in the pharmaceutical and biopharmaceutical industry. We have relationships with the top pharma companies as well as small start-up organizations. We support generic, innovator and consumer health companies with their IND, NDA, ANDA, and 505(b)(2) submissions and provide flexible solutions that are customized to each client’s needs.

We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We successfully assist clients to advance hundreds of molecules through development to commercial launch in global markets.

Our wide breath of laboratory and clinical services offer our clients solutions over the entire spectrum of the product development pipeline ranging from discovery through late-stage development.

• Our laboratory services offerings include DMPK, Bioanalytical, and CMC. With over 16 years of experience, we have over 400 scientists in 3 facilities located in the USA and China. Our senior scientists average 10 – 15 years in complex drug development and many come from leading Pharmaceutical companies.

• Our clinical services portfolio includes Phase I-IIa and biometrics services. We have 160 beds in our Secaucus NJ clinic and 18 sites with over 300 beds in China. Our Biometrics services supports Early to late stage programs.

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Our Services (110)


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IND-Enabling Studies

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Cold Chain Logistics

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Clinical Biomarkers

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  • Fit-for-purpose (FFP) and Exploratory Biomarkers
  • Validation differences depending on the purpose of study and method categories
  • Method validation to support Labelling Claims, Safety, Efficacy
  • Significant endogenous levels of biomarker(s) of interest
  • Parameters of validation and level of “compliance” (fit-for... Show more »
  • Fit-for-purpose (FFP) and Exploratory Biomarkers
  • Validation differences depending on the purpose of study and method categories
  • Method validation to support Labelling Claims, Safety, Efficacy
  • Significant endogenous levels of biomarker(s) of interest
  • Parameters of validation and level of “compliance” (fit-for purpose), methodology and SOPs
  • Define assay precision
  • Variety of platforms available (based on the endogenous biomarker amount in the matrix
  • Shared samples for many biomarkers
  • Complexity around analysis of “multiplex” data
  • Healthy vs Diseased performance differences
  • Potentially different locations, labs, companies, instrumentation,
  • Sample collection, processing and shipping inconsistencies
  • Matrix selection & volumes
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ELISA ELLA Luminex®

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In vitro Immunogenicity Assays

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Regulatory Writing

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HT ADME

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Radiotracers and Radiopharmaceuticals

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  • Mechanistic or Routine Studies
  • Synthesis of Stable Isotopes for Metabolic studies (13C, 2H)
  • Radiolabeled compounds (14C, 3H) for Metabolic studies
  • Mass Balance, excretion, Distribution
  • Mechanistic or Routine Studies
  • Synthesis of Stable Isotopes for Metabolic studies (13C, 2H)
  • Radiolabeled compounds (14C, 3H) for Metabolic studies
  • Mass Balance, excretion, Distribution
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Technology Transfer and Licensing

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Agrochemical Testing

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We offer residual analyses, syntheses of metabolite standards and GLP in vivo/in vitro studies with radiolabeled compounds.

• Animal, plant and soil metabolism
• In vitro/In vivo studies
• GLP mass balance studies
• Bioanalytical studies
• Chemistry support
• Syntheses of metabolite standards
• Physical/chemical profiling
• Product certification
• Formulation stability

We offer residual analyses, syntheses of metabolite standards and GLP in vivo/in vitro studies with radiolabeled compounds.

• Animal, plant and soil metabolism
• In vitro/In vivo studies
• GLP mass balance studies
• Bioanalytical studies
• Chemistry support
• Syntheses of metabolite standards
• Physical/chemical profiling
• Product certification
• Formulation stability

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Tablet Presses

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Tablet Press Control Systems

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Product Stability Testing

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R&D Services

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Contract Services Directory

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Drug Preformulation

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In vivo Drug Efficacy Testing

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Preclinical Study Design

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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The highly trained and experienced scientific team provides broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data. We offer extensive drug metabolism and pharmacokinetic capabilities for new chemical entities and compounds in development.

The highly trained and experienced scientific team provides broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data. We offer extensive drug metabolism and pharmacokinetic capabilities for new chemical entities and compounds in development.

  • Structural Optimization in Early Discovery
  • Pharmacokinetic Studies in Rodents, Dogs & NHP
  • In Vitro ADME (Discovery & Development)
  • Non-GLP Bioanalytical Studies
  • Radiolabel Studies (including Mass Balance)
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Mouse Rat Dog Rodents Non-human primates (NHP)

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Clinical Trial Packaging

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Mass Spectrometry

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Clinical Trials Supply Manufacturing

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Batch Release Testing

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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
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Animal Model in vivo Analyses

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Radiolabeled and non-labeled compounds
Single and multiple dose studies
Multiple species (mice, rats, dogs, monkeys, minipigs)
Oral, dermal, IP, SQ, IV
Special surgical techniques
Bile duct/hepatic portal vein
Metabolite identification/quantitation

Radiolabeled and non-labeled compounds
Single and multiple dose studies
Multiple species (mice, rats, dogs, monkeys, minipigs)
Oral, dermal, IP, SQ, IV
Special surgical techniques
Bile duct/hepatic portal vein
Metabolite identification/quantitation

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Mouse Rat Dog Non-human primates (NHP) Minipig

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HPLC

High Performance Liquid Chromatography
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Granulation/Compaction/Agglomeration

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GMP Auditing

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GLP Auditing

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Controlled Release Systems

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Pharmaceutical Formulation

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Industrial Design

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Extractable and Leachable Testing

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Clinical Electronic Data Capture (EDC)

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Drug Discovery

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Drug Development

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De Novo Drug Design

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Drug Delivery Systems

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Dosage Form Development

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Drug Master File (DMF) Submission and Maintenance

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Clinical Supply Chain Management and Logistics

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Solubility and Dissolution Testing

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Data Management

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Pharmaceutical Manufacturing

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Contract Research

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Consulting

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Phase I Clinical Trials

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Clinical Sample Analysis

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Gas Chromatography (GC)

Gas Chromatography
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Chemical Analysis

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Blending

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Biopharmaceutical Development

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Biometrics

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Biomarker Analysis

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Frontage Laboratories is the first CRO to validate multiple SimoaTM (Single Molecule Array) instruments in a GLP regulated environment. SimoaTM technology provides a novel and ultra-sensitive method for detecting and quantifying biomolecules in biological specimens at femtomolar concentrations. This very low-level detection is... Show more »

Frontage Laboratories is the first CRO to validate multiple SimoaTM (Single Molecule Array) instruments in a GLP regulated environment. SimoaTM technology provides a novel and ultra-sensitive method for detecting and quantifying biomolecules in biological specimens at femtomolar concentrations. This very low-level detection is difficult or impossible to measure on other instrument platforms. The sensitivity of Quanterix Simoa analyzer makes it the instrument of choice for ultra-sensitive analysis of biomarkers.

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Biomarker Discovery

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Biopharmaceutical Process Development

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Biological Testing

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Bioanalytical Analysis LC/MS/MS

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Hamilton® Robotic Liquid Handler Simoa HD-1 Analyzer™ MSD MESO SECTOR® S 600 Sciex API 6500, 5500, 5000, 4000 MS

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Assay Development

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Animal Model Housing and Maintenance

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Analytical Method Validation

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Analytical Method Development

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Analytical Chemistry Services

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Accelerated Stability Testing

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Clinical Ancillary and Sample Services

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Spectroscopy

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Marketing, Communication & Graphic Design Services

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Immunoassays

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In vitro Disease Models

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Formulation Services

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Liquid Chromatography (LC)

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Data Services

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Clinical Drug Management

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Bioanalysis

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Frontage’s experienced bioanalytical scientists support a full suite of services using state-of-the-art instru­mentation

  • Biomarker Services
  • Preclinical and Clinical Support
  • Global Bioanalytical Services (65+ LC-MS/MS)
  • Biologics Assay (Antibody Drug, ADC, Oligonucleotide)

Our expertise includes development of more... Show more »

Frontage’s experienced bioanalytical scientists support a full suite of services using state-of-the-art instru­mentation

  • Biomarker Services
  • Preclinical and Clinical Support
  • Global Bioanalytical Services (65+ LC-MS/MS)
  • Biologics Assay (Antibody Drug, ADC, Oligonucleotide)

Our expertise includes development of more than 1400 proprietary and non-pro­prietary methods and the yearly throughput of more than 500,000 samples analyzed in regulated, GLP and GCP settings

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Automated liquid handler Thermo Orbitrap Hamilton® Robotic Liquid Handler Simoa HD-1 Analyzer™ MSD MESO SECTOR® S 600 Sciex API 6500, 5500, 5000, 4000 MS Sciex API 6600 Q TOF MS Waters Xevo® TQ-S MS Thermo LTQ™ Agilent 7700x ICP-MS SpectraMax® Smax L Plate Reader FlexStation® Plate Reader ChemiDoc™ Imaging System Covaris AFA Ultrasonic Extraction Instruments Gyros Workstation GC-MS LC-MS/MS ICP-MS Meso Scale Discovery (MSD®) Luminex® Show 20 more tags Show less

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Hit Identification

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Animal Models and Studies

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Mouse Rat Dog Non-human primates (NHP) Minipig

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Bioanalytical Assays

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Manufacturing Services

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Drug Discovery & Development

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Clinical Trials, Consulting, and Management

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Regulatory Affairs Services

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Product Quality Control

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Clinical Research

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Antibody/Antigen Detection Based Testing

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Agricultural Testing

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Agricultural Testing Services

_Residue Chemistry-
• Field soil dissipation
• Magnitude of the residue
• Crop field trials & storage stability
• Livestock feeding studies (cattle, poultry)
• Analytical methods development
• Independent Laboratory Validations (ILV)

Metabolism

Plant Metabolism

Agricultural Testing Services

_Residue Chemistry-
• Field soil dissipation
• Magnitude of the residue
• Crop field trials & storage stability
• Livestock feeding studies (cattle, poultry)
• Analytical methods development
• Independent Laboratory Validations (ILV)

Metabolism

Plant Metabolism

  • Metabolite identification
  • Metabolite (cold) synthesis
  • Distribution studies
  • Reincorporation methodology (14C)
  • Greenhouse Facilities

Animal Absorption, Distribution, Metabolism and Excretion

  • Radiolabeled and non-labeled compounds
  • Single and multiple dose studies
  • Multiple species (mice, rats, dogs, monkeys, minipigs)
  • Oral, dermal, IP, SQ, IV
  • Special surgical techniques
  • Bile duct/hepatic portal vein
  • Metabolite identification/quantitation
  • Nature of the residue studies

Environmental Fate
Degradation (hydrolysis, photodegradation)
Aerobic and anaerobic metabolism (soil, aquatic)
Mobility (absorption/desorption, soil column leaching)
Fish bioaccumulation (metabolite identification)
Analytical Support
Confined accumulation (rotational crop)
Field rotational crop

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Agriscience

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Agriscience Services

Agriscience Services

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Educational Services

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Pharmacology & Toxicology

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You will find Frontage is outstanding at performing pivotal biosciences research. We offer pivotal toxicology studies for safety toxicity and toxicity evaluation of candidate compounds. Our toxicological studies are conducted on a variety of animal models, ranging from IND-enabling to smaller tox studies, and provide a basis for... Show more »

You will find Frontage is outstanding at performing pivotal biosciences research. We offer pivotal toxicology studies for safety toxicity and toxicity evaluation of candidate compounds. Our toxicological studies are conducted on a variety of animal models, ranging from IND-enabling to smaller tox studies, and provide a basis for identifying hazards and conducting safety assessments that support IND filing and support use in humans. Our IND-enabling toxicology is performed by experienced scientists who can recommend appropriate study parameters and protocol elements, enabling the collection of a robust and comprehensive data package for IND submission. We offer comprehensive expertise to execute your IND study needs with services optimized to meet the most aggressive execution timelines.

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Mouse Rat Dog Rodents Minipig LC-MS/MS Show 6 more tags Show less

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Cells and Tissues

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In vitro ADME/DMPK Studies

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Biostatistics & Bioinformatics

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Synthetic Chemistry

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Product Development, Testing, and Packaging

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Radiochemistry

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Pharmacology

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Pharmacology Services

Pharmacology Services

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Chemistry and Materials

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Clinical Laboratory Services

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Biomarkers

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Project Management

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Computational Modeling

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Imaging & Spectroscopy

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Clinical Data Collection, Analysis and Management

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Packaging Services

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Separation/Purification Services

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Editorial and Writing Services

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Biology

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Clinical Bioavailability/Bioequivalence Studies

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Chromatography

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Business Development, Marketing & Operations

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Clinical Chemistry

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Business Operations and Logistics Support

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Business Operations and Logistics Support Services

Business Operations and Logistics Support Services

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  • Positive review for ADME/DMPK Studies:

    January 2019

    "Frontage Laboratories is a great scientific and technical partner for all drug discovery and development activities. Their staff is highly professional and responsive to customer needs and timelines. The work is schedule quickly, the data generated is of high quality as are the reports."

Frontage Laboratories has not received any endorsements.