Method Development & Validation CROs in United States

Biologics CDMO providing GMP manufacturing of viral vaccines, recombinant proteins, and gene therapy vectors from BSL-2/3 facilities, with particular expertise in infectious disease and oncology.

Contract research and manufacturing organization offering drug discovery, API synthesis, analytical development, and formulation services to global pharma and biotech.

Specialty bioanalytical and analytical CRO providing method development, validation, and sample analysis services for pharmaceutical and biotech companies pursuing FDA submissions.

Contract analytical laboratory providing USP dissolution testing, method development, and stability studies for solid oral dosage form characterization under FDA guidelines.

San Diego-based CDMO providing small and large molecule API manufacturing, oligonucleotide synthesis, and ADC conjugation services from pre-clinical through commercial scale.

CDMO providing custom API development and manufacturing, solid dose and sterile formulation, analytical testing, and clinical and commercial supply from multiple US facilities.

Specialist bioanalytical CRO combining LC-MS/MS, mass spectrometry imaging, and spatial biology platforms to support regulated discovery and clinical sample analysis.

GLP-compliant bioanalytical CRO with 25+ years of LC-MS/MS and GC-MS/MS expertise supporting preclinical-to-clinical drug development from purpose-built facilities.

Full-service CRO integrating translational sciences, clinical pharmacology, bioanalysis, and regulatory strategy from preclinical through Phase IV development.

Specialty preclinical CRO offering bioanalytical chemistry, in vitro ADME screening, physicochemical profiling, and metabolite identification for drug discovery programs.

Clinical pharmacology and bioanalytical CRO providing Phase I studies, bioequivalence, and PK/PD studies from a purpose-built 150-bed clinical pharmacology unit in Dilworth, Minnesota.

Independent nonprofit applied science and technology organization providing preclinical research, inhalation toxicology, bioanalytical services, and pharmaceutical development support.

World's largest nonprofit R&D organization offering GLP-compliant preclinical safety, toxicology, inhalation studies, and bioanalytical services including BSL-3 biocontainment capabilities.

Leading large molecule bioanalytical CRO specializing in ligand-binding assays, immunogenicity testing, flow cytometry, and biomarker analysis for biologics drug development.

Leading CDMO providing API development and manufacturing services including custom synthesis, generic APIs, and advanced intermediates from facilities across the US and Europe.

Specialized early clinical research CRO providing Phase I clinical pharmacology, bioanalytical, and ADME services from dedicated clinical units.

Labcorp's contract development and manufacturing arm providing formulation development, analytical services, stability testing, and clinical trial manufacturing for small molecules and biologics.

Leading analytical and testing laboratory providing stability testing, extractables and leachables, raw material testing, and method development for pharmaceutical and food industries.

Specialty genomics laboratory providing biomarker services, companion diagnostics, and genomic profiling for clinical trials. Part of LabCorp Drug Development.

CDMO offering integrated drug discovery, development, and manufacturing services including API production, drug product manufacturing, and analytical services from facilities in the US, Europe, and India.

San Diego-based CRO specialising in dermatology clinical trials with proprietary non-invasive skin sampling technology for melanoma and inflammatory skin disease studies.

US CDMO providing drug substance manufacturing, fill-finish, and device assembly services for biologics, vaccines, and cell/gene therapy products.

CDMO division of Eurofins providing process development, analytical development, and GMP manufacturing for biopharmaceutical products including monoclonal antibodies and recombinant proteins.

Specialty reference laboratory providing clinical trial testing services including infectious disease biomarker analysis, transplant diagnostics, and immunogenicity testing for clinical studies.

Top-tier biologics CDMO offering cell culture, microbial fermentation, and cell and gene therapy manufacturing across US sites supporting 128+ regulatory approvals.

Clinical trial arm of Frontage Laboratories providing Phase I-III services with integrated bioanalytical capabilities, bridging bioanalytical strength with full clinical execution.

CRO providing integrated drug discovery and development services including ADME/PK, bioanalytical, CMC, and clinical services with operations in the US and China.

Analytical services CRO specializing in subvisible particle characterization, aggregation analysis, and container closure integrity testing for biologics and pharmaceutical products.

ICON's dedicated bioanalytical division providing GLP-compliant small and large molecule bioanalysis, immunogenicity testing, and biomarker analysis from state-of-the-art laboratories.

Specialised bioanalytical laboratory in New York providing large-molecule bioanalysis, immunogenicity testing, and ligand-binding assay development for biologics programmes.

US biologics CDMO providing cell line development, process development, cGMP manufacturing, and analytical services for monoclonal antibodies, recombinant proteins, and gene therapy products.

Leading bioanalytical CRO with 45+ years of experience supporting 315+ approved drugs, offering LC-MS, ELISA, flow cytometry, and immunogenicity assays.

Pennsylvania-based bioanalytical CRO providing GLP-compliant LC-MS/MS and ligand-binding assay services for PK, immunogenicity, and biomarker analysis.

Specialist topical and transdermal formulation development CRO and CDMO offering dermal PK, in vitro permeation, bioequivalence, and formulation development services.

North Carolina-based CDMO specialising in oral solid dosage formulation development, analytical services, and cGMP clinical supply manufacturing for Phase I-III.

Quality control reference material provider and testing laboratory serving pharmaceutical, medical device, and clinical diagnostics industries with microbiology standards.

Premier provider of sterilization validation, microbiology, and biocompatibility testing services for medical devices. Part of Sotera Health, serving the global healthcare industry.

Founder-led bioanalytical CRO providing GLP-compliant LC-MS, ELISA, and qPCR services for PK, immunogenicity, and biomarker assays for pharma and biotech.

Specialized CDMO focused exclusively on sustained-release long-acting injectable formulation development, aseptic fill-finish, and lyophilization.

US-based contract analytical laboratory providing GMP/GLP method development, validation, stability testing, and extractables/leachables studies for pharmaceutical and biotech sponsors.

Bioanalytical CRO providing GLP-compliant LC-MS/MS and ligand binding assay services for pharmacokinetic, bioequivalence, and immunogenicity sample analysis to support clinical trials.

California-based bioanalytical CRO providing LC-MS/MS method development, validation, and sample analysis for PK/PD studies supporting IND and NDA submissions.

Bioanalytical and testing laboratory in the San Francisco Bay Area providing biocompatibility testing, extractables and leachables, sterility, and analytical chemistry services for pharma and medical devices.

San Francisco Bay Area testing laboratory providing biocompatibility, extractables/leachables, sterility, and microbiology testing for medical devices and pharmaceutical products.

Specialty preclinical CRO focused on Asia-Pacific markets, providing preclinical safety assessment, pharmacology, and bioanalytical services for small molecule and biologic programs.

California-based cGMP testing laboratory providing raw material testing, stability studies, extractables/leachables, and method development for pharmaceutical and biotech clients.

Major global CDMO providing end-to-end pharmaceutical development and manufacturing services including drug substance, drug product, and commercial manufacturing under the Thermo Fisher Scientific umbrella.

Missouri-based CDMO providing oral solid dosage development and manufacturing including tablets, capsules, sachets, and effervescent forms from R&D through commercial scale.

Global CRO providing bioanalytical, clinical pharmacology, and Phase I-IV clinical trial services. QPS operates CLIA-certified bioanalytical laboratories supporting regulated studies.

Specialty CRO providing GLP toxicology testing, biocompatibility evaluation, and analytical chemistry services for medical devices, combination products, and pharmaceutical excipients.

Translational pharmaceutics CRO/CDMO uniquely combining formulation development and clinical pharmacology under one roof, accelerating drug development timelines by running formulation and clinical testing simultaneously.

Specialist bioanalytical, biomarker, and analytical sciences CRO with 500+ experts providing FDA/EMA-inspection-ready regulated bioanalysis across the US, UK, and Australia.

Contract research organization providing discovery, preclinical, and development chemistry services including API synthesis, safety pharmacology, and medicinal chemistry.

Clinical-stage diagnostics and genomic testing company providing companion diagnostic development and biomarker-driven clinical trial services.

Maryland-based cell therapy development company providing iPSC-derived cell therapy manufacturing, process development, and analytical services for clinical-stage gene and cell therapy programs.

Mid-size full-service global CRO offering integrated bioanalytical lab services alongside Phase I-IV clinical trial management with a focus on CNS, cardiovascular, and rare disease.

WuXi AppTec's cell and gene therapy division providing GMP viral vector manufacturing, cell therapy manufacturing, and plasmid DNA production from US and China facilities.

New Jersey-based bioanalytical and ADME/DMPK CRO founded in 1987, providing clinical and nonclinical metabolism and pharmacokinetics services to pharma, biotech, and agrochemical industries.

Specialty ADME/PK CRO providing in vitro and in vivo drug metabolism and pharmacokinetic studies. Known for comprehensive ADME characterization using human and animal tissues.

Kansas City-based in vitro ADME and drug metabolism CRO providing hepatocyte-based assays, enzyme induction/inhibition studies, and metabolite identification services.