Method Development & Validation CROs

Leading CDMO providing custom development and manufacturing for the pharmaceutical and biotech industries. Lonza specializes in biologics, cell and gene therapy, and small molecule manufacturing.

Leading global pharmaceutical and medical device open-access capability and technology platform. WuXi AppTec provides services spanning from discovery through manufacturing across small molecules, biologics, and cell/gene therapies.

International group of laboratories providing testing and support services to the pharmaceutical, food, environmental, and consumer products industries. Major provider of bioanalytical and analytical testing services.

World's leading testing, inspection, and certification company. SGS provides pharmaceutical analytical services, clinical research, and regulatory compliance testing globally.

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

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

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

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

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

Australian CDMO providing API manufacturing, sterile fill-finish, and pharmaceutical development services from TGA-licensed and FDA-registered facilities in Melbourne.

Leading CDMO providing end-to-end biopharmaceutical manufacturing services including cell line development, process development, and commercial manufacturing at massive scale.

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

Mid-size CRO offering early-phase clinical studies, preclinical safety assessment, and bioanalytical services. Known for integrated PK/PD programs from preclinical through Phase I.

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

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

Global testing and certification provider offering comprehensive pharmaceutical services including analytical testing, stability studies, extractables/leachables, and regulatory consulting.

Integrated drug discovery and development services company now part of Evotec. Provides ADME/DMPK, safety assessment, and pharmaceutical development services.

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

Translational pharmaceutics CRO integrating drug substance, drug product, and clinical testing in a single facility. Specializes in formulation development with integrated Phase 1 studies.

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

Dutch CDMO specialising in controlled substance manufacturing and schedule I-V API synthesis for clinical trial and commercial supply under DEA and EMA licences.

UK-based CDMO specialising in inhaled drug product development including dry powder inhalers, metered dose inhalers, and nasal spray formulations.

Ireland-based specialty pharmaceutical development group providing formulation, analytical, and clinical supply services for oral, topical, and injectable dosage forms.

Indian bioanalytical and clinical research laboratory providing BA/BE studies, pharmacokinetic analysis, and analytical method development for generic and innovative drug programs.

Ahmedabad-based CRO with a 350-bed Phase I clinical pharmacology unit, specializing in early-phase clinical trials, BA/BE studies, and bioanalytical services for global pharma clients.

CDMO headquartered in Northern Ireland providing GMP API synthesis, drug product development, clinical trial supply manufacturing, and biomarker services across North America and Europe.

Fully integrated German CRO/CDMO offering drug discovery, non-clinical studies, pharmaceutical analysis, GMP manufacturing, and early-phase clinical trials from facilities in Germany and France.

Danish biomarker CRO specializing in neoepitope biomarker technologies for tissue remodeling, conducting clinical trials in rheumatology, musculoskeletal, and metabolic disease with CAP-accredited laboratories.

Eurofins Discovery division providing high-throughput in-vitro pharmacology screening, compound profiling, ADME assays, and bioanalytical services supporting drug discovery from target identification through lead optimization.

Independent pharmaceutical development services company in Basel providing drug formulation development, analytical development, and stability testing for injectable and biopharmaceutical products.

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

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

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

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

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

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.

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

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

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.

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.

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.

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.

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

Indian clinical CRO providing Phase I-IV clinical trials, bioanalytical services, and clinical pharmacology studies with dedicated Phase I units and bioanalytical laboratories.

Indian biopharmaceutical company providing biosimilar development, contract manufacturing, and clinical research services with GMP manufacturing facilities for biologics and biosimilars.

Chinese CDMO providing API development and manufacturing services including custom synthesis, process development, and commercial-scale production from multiple GMP-certified facilities.

Chinese CDMO providing pharmaceutical development and manufacturing services from drug discovery to commercialization, known as a long-term supplier to major pharmaceutical companies including Pfizer.

Indian CRO providing Phase I clinical pharmacology, bioanalytical services, and bioequivalence studies from a 230-bed clinical pharmacology unit in Ahmedabad with USFDA and EMA track record.

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

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

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

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

Global biologics CDMO providing end-to-end solutions for biologics drug development and manufacturing including monoclonal antibodies, bispecific antibodies, ADCs, and cell and gene therapies.

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

Australian bioanalytical CRO providing GLP-compliant LC-MS/MS and ligand binding assay services for pharmacokinetic, bioequivalence, and immunogenicity studies supporting global regulatory submissions.

WuXi AppTec's pharmaceutical development and manufacturing arm providing API process development, formulation development, analytical services, and GMP manufacturing from China and US facilities.

Chinese CRO and CDMO providing drug discovery chemistry, DMPK, analytical services, and clinical trial manufacturing from Shanghai and Chengdu operations.

South Korean biosimilar developer and CDMO providing biologics development, manufacturing, and analytical services with a portfolio of approved biosimilar products across global markets.

South Korean biopharmaceutical company providing biosimilar development and cGMP biologics manufacturing with one of the largest mammalian cell culture facilities in the world.

Eurofins' Indian bioanalytical and pharmaceutical testing operations providing method validation, stability testing, and raw material analysis for pharmaceutical companies.

Chinese operations of Frontage Laboratories providing bioanalytical services, ADME/PK studies, and analytical chemistry from GLP-compliant laboratories in Shanghai and Suzhou.

CMIC Group's contract manufacturing arm providing GMP drug product manufacturing, formulation development, and packaging services from Japanese facilities.

Japanese preclinical ADME services company providing in vitro metabolism, transporter, and drug interaction studies using human and animal tissue preparations for drug development.

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.

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.

UK-based bioanalytical and pharmaceutical testing CRO providing LC-MS/MS, dissolution testing, and method validation services for generic and innovator pharmaceutical companies.

European laboratory services provider offering central laboratory, bioanalytical, and diagnostic testing services for clinical trials across Phase I-IV with 40+ labs worldwide.

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

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.

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

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

Hyderabad-headquartered integrated CRDMO providing CRO and CDMO solutions for small and large molecules to 450+ global pharma and biotech clients with 3,000+ professionals.

Ahmedabad-founded full-service CRO and one of Asia's largest BA/BE and early-phase Phase I units, offering clinical, bioanalytical and biometric services across 4 countries.

ASX-listed Taiwanese CDMO providing world-class API synthesis, finished dose form manufacturing, and clinical packaging from GMP facilities in the Southern Taiwan Science Park.

Shanghai-headquartered CRO/CDMO offering integrated drug discovery chemistry, biology, and biologics development services including ADC and recombinant protein production.

Ahmedabad-based mid-size CRO providing Phase I-IV clinical trials, bioequivalence studies, and bioanalytical services to Indian and global generic pharma companies.

South Korean genomics and CRO company providing next-generation sequencing, genomic analysis, and precision medicine research services alongside clinical biomarker and pharmacogenomics programs.

Bangalore-based CRO subsidiary of Biocon offering early-phase clinical trials, bioequivalence studies, bioanalytical testing and Phase II-IV services with expertise in biosimilars.

Germany-based mid-size CRO providing early-phase clinical trials (Phase I/IIa), bioanalysis, DMPK, and translational medicine services from facilities in Neu-Ulm and Berlin.

Spanish CDMO specialising in oral solid dosage form development, hot-melt extrusion, spray drying, and GMP clinical supply manufacturing for early-phase programmes.

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

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.

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

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

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

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

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

European ADME and DMPK specialist CRO providing in vitro ADME screening, drug-drug interaction studies, and physicochemical profiling from Macclesfield and Watertown facilities.

Indian CRO providing Phase I BA/BE studies, bioanalytical testing, clinical pharmacology and early-phase research services with USFDA-inspected facilities in Navi Mumbai.

Bangalore-based Indian CRO offering Phase I bioequivalence, bioanalytical and early-phase clinical research services for domestic and international generic pharmaceutical companies.

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

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

Hyderabad-based publicly listed contract research and testing organisation offering integrated preclinical, clinical, and cGMP laboratory services for pharmaceutical companies worldwide.

India-based integrated CDMO and CRO providing API R&D, formulation development, bioanalytical services, and Phase I-IV clinical research from facilities in Hyderabad.

Bangalore-based Indian CRO specialising in Phase I-IV clinical trials, bioequivalence studies, and regulatory affairs for domestic and international pharmaceutical companies.

Tunis-based CRO covering most African countries, offering clinical research services, WHO-certified bioequivalence studies, regulatory submissions, pharmacovigilance, and pharmaceutical training.

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

Canadian bioanalytical CRO providing GLP-compliant LC-MS/MS bioanalytical services, PK analysis, and method development for pharmaceutical and biotech sponsors.

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

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

Glasgow-based specialty virology and biosafety testing CRO providing viral clearance validation, adventitious agent testing, and mycoplasma testing for biologics manufacturers.

Belgian CDMO providing integrated drug substance and drug product development from early-phase API synthesis through formulation, analytical development, and GMP manufacturing.

Global precision medicine CRO delivering biomarker and bioanalytical services including flow cytometry, histopathology, proteomics, and genomics for clinical trials.

One of China's earliest chemistry-focused CROs offering integrated drug discovery, DMPK, and pharmaceutical development services globally.

Swiss CDMO providing integrated drug substance and drug product development services including API synthesis, process development, and highly potent compound manufacturing.

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

US-German CDMO specialising in viral vector and oncolytic virus manufacturing for gene therapy and immuno-oncology clinical programmes.

Montreal-based analytical CRO providing GMP method development, stability testing, and extractables/leachables analysis for pharmaceutical and biologics sponsors.

High-performance Brazilian clinical research CRO now part of QIMA Life Sciences, specialising in bioequivalence, Phase I-III trials, and ANVISA regulatory strategy.

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

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

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

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

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

Netherlands-based bioanalytical centre of excellence providing large-molecule bioanalysis, immunogenicity, and cell-based assay services for biologics and biosimilar programmes.

LabCorp Drug Development centre in Basel providing central laboratory services, companion diagnostics development, and specialised clinical testing for European pharma sponsors.

European CDMO network with 11 GMP facilities providing integrated API, drug product, and packaging services from pre-clinical through commercial scale including peptides, lipids, and injectables.

Greek CDMO specialising in long-acting injectable (LAI) and controlled-release oral solid dosage development and manufacturing for complex generics and NCEs.

French CDMO specialising in topical, semi-solid, and liquid pharmaceutical manufacturing for clinical trial supply and commercial production.

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

Jakarta-based Indonesian CRO and bioanalytical laboratory providing BA/BE studies, clinical trials, and analytical services for pharmaceutical companies seeking Indonesian regulatory approval.

Amman-based Jordanian CRO and pharmaceutical company providing bioequivalence studies, BA/BE clinical trials, and contract analytical services for MENA pharmaceutical markets.

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

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.

Nuvisan's Integrated Contract Bioscience facility in Neu-Ulm, Germany, providing preclinical ADME, bioanalysis, and Phase I clinical trials with a 120-bed clinical pharmacology unit.

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

SGS's Belgian life sciences hub providing bioanalytical testing, method validation, and quality control services for pharmaceutical and biotech clients from GLP/GMP-certified laboratories.

GLP/GMP-certified European bioanalytical and CMC CRO near Barcelona with four laboratories and 240 experts serving the full pharmaceutical product lifecycle since 2001.

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

Canadian Phase I and bioequivalence CRO with a 150-bed clinical facility in Toronto and over 2,500 completed BA/BE and early-phase studies for global pharma clients.

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.

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.

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