FDA Registered Certified CROs

Global leader in drug delivery technologies and development solutions. Catalent provides formulation, development, and manufacturing services for pharmaceuticals, biologics, and consumer health products.

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.

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.

Exton, Pennsylvania-based preclinical CRO providing in vivo PK/PD studies, ADME services, and GLP bioanalytical testing for small-molecule and biologic drug candidates.

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

Clinical development and strategic resourcing organization providing full CRO services and functional service provider models to biopharma companies since 1994.

Leading IRB, IACUC, and consulting services provider for clinical and preclinical research, plus site management and performance optimization services.

European CDMO with 13 production sites across seven countries providing oral solid dose, softgel, and sterile manufacturing for pharma and biotech clients.

US-based CRO providing full-service Phase I-IV clinical trial support for small and mid-size pharma and biotech with expertise in CNS, oncology, and infectious disease.

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

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.

US-based contract pharmaceutical company providing tableting, encapsulation, powder blending, packaging, and clinical supply manufacturing services for oral solid dosage forms.

Full-service CRO purpose-built for small and mid-size biotech, combining legacy of CATO Research, SMS Oncology, Pharm-Olam, and Nuventra into an integrated clinical development partner.

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

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 based near FDA headquarters with 25+ years of regulatory and clinical trial expertise including adaptive designs, BE/BA studies, and pharmacovigilance.

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

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.

Phase I-III oncology CRO providing clinical trial management with deep oncology expertise for small and mid-size pharma and biotech sponsors.

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.

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

Preclinical CRO specialising in immunotoxicology and immune safety assessment, offering in vivo and in vitro studies for pharma, biotech, and government clients.

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

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

Full-service mid-size CRO specialising in rare diseases, transplantation, nephrology, and immunology across Phase I-IV trials.

Preclinical CRO in Pennsylvania providing GLP and non-GLP toxicology, safety pharmacology, and pathology services with a focus on small and large molecule therapeutics.

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

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

The only global full-service CRO focused exclusively on CNS drug development, with involvement in 22 FDA-approved CNS therapies across 13 indications.

New York-based Phase I CRO operating an 80-bed clinical pharmacology unit for first-in-human, CNS, cardiac safety, and abuse liability studies.

Pennsylvania-based dermatology and aesthetics specialty CRO providing Phase I-IV clinical trial management and site services for topical, injectable, and device-based products.

GLP-compliant preclinical CRO specializing in toxicology, pathology, and ADME studies for pharmaceutical, biotech, and agrochemical clients with full necropsy and histopathology capabilities.

US-based clinical-stage CRO arm specialising in endocrinology and cortisol-modulation therapeutics with expertise in Phase I-III metabolic and CNS clinical trials.

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.

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.

LabCorp Drug Development preclinical and toxicology centre in Madison, Wisconsin, providing GLP-compliant general and genetic toxicology, safety pharmacology, and reproductive toxicology studies.

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.

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

Global tech-enabled full-service CRO with strength in government-sponsored trials, infectious disease, vaccines, ophthalmology, and rare disease clinical development.

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

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.

Global real-world evidence and outcomes research firm providing observational studies, health economics, market access, and regulatory evidence generation for pharma and biotech.

Specialty CRO providing GLP-compliant anatomic pathology, histotechnology, and immunohistochemistry services for pharma, biotech, and government preclinical research programs.

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

Texas-based Phase I clinical research unit specialising in early-phase, first-in-human, and healthy volunteer studies with integrated bioanalytical capabilities.

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.

Hungarian pharmaceutical company's CDMO division offering API synthesis, steroids manufacturing, and hormone product development from GMP-certified facilities.

Phase I clinical research unit in New Jersey providing first-in-human, food effect, bioequivalence, and early-phase pharmacokinetic studies for pharmaceutical sponsors.

German CDMO specialising in sterile liquid fill-finish, lyophilisation, and oral solid dosage manufacturing for clinical and commercial supply.

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

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

Independent not-for-profit preclinical CRO offering full IND-enabling GLP toxicology programs, inhalation toxicology, and immunogenicity testing from the Illinois Institute of Technology campus.

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

North Carolina-based genetic toxicology CRO providing GLP-compliant Ames, micronucleus, chromosomal aberration, and comet assays for regulatory submissions.

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

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.

US-Korea bridge CRO providing early-phase clinical and regulatory services tailored for Korean life science companies entering the US FDA pathway.

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

Phase I-III CRO and integrated research site network specialising in CNS, pain, obesity, and metabolic disease with wholly-owned clinical units in California.

Not-for-profit preclinical CRO with ABSL-3 capabilities and expertise in inhalation toxicology, pulmonary delivery, and infectious disease models from 100+ acre campus.

Large preclinical CRO in Michigan acquired by Charles River Laboratories, providing GLP toxicology, safety pharmacology, and ADME studies in purpose-built facilities spanning over 800,000 sq ft.

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

Oncology CRO founded by oncology thought-leaders specializing in Phase I and II immuno-oncology trials in North America and Europe.

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.

Specialist CDMO for cell and gene therapy products offering GMP clinical and commercial manufacturing and development solutions for ATMPs from German, US, and Japanese facilities.

Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.

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

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

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

US arm of Australian CRO Nucleus Network, operating early phase clinical trials from their Minneapolis facility. Provides Phase 1 studies with access to diverse patient populations.

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.

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.

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

Gene therapy-focused CDMO providing viral vector manufacturing for adeno-associated virus (AAV) gene therapies, acquired by Catalent to expand biologics capabilities.

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.

Integrated pharmaceutical R&D service platform offering drug discovery, preclinical, clinical, and commercial manufacturing services to biotech and pharma companies globally.

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

Global CDMO offering end-to-end pharmaceutical development and manufacturing including API synthesis, oral solid dose, sterile fill-finish, and antibody-drug conjugate manufacturing.

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

Specialty CRO focused on oncology and rare disease with 2,000+ professionals, known for biomarker-driven trial design, companion diagnostics, and translational research services.

Global regulatory consulting, pharmacovigilance, and clinical research organization providing single-source regulatory strategy, compliance, and medical information services.

Specialty CRO focused on cardiometabolic clinical trials. Operates Phase 1–2 studies for obesity, diabetes, NASH/MASH, and cardiovascular endpoints with proprietary biomarker platforms.

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.

Leading CDMO providing pharmaceutical manufacturing services including development, scale-up, and commercial production of oral solids, sterile products, and complex formulations.

Oklahoma-based early-phase clinical research site specialising in Phase I healthy volunteer studies, PK/PD trials, and bioequivalence studies.

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

Full-service CRO providing clinical research, biostatistics, data management, and regulatory services with particular expertise in ophthalmology, CNS, and rare disease.

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

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

US subsidiary of Shin Nippon Biomedical Laboratories specializing in GLP preclinical safety assessment including general toxicology, reproductive toxicology, and inhalation studies with NHP and rodent capabilities.

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

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

Decentralized CRO enabling fully virtual and hybrid clinical trials through a proprietary Metasite platform, reducing site burden and improving patient access.

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.

Global clinical supply packaging and distribution company providing clinical trial materials management, packaging, labeling, and worldwide distribution from facilities in the US and Europe.

Indiana-based aseptic fill-finish CDMO specialising in small-batch sterile injectable manufacturing for cell therapies, gene therapies, and biologics.

Nonprofit research organization providing drug discovery, preclinical development, and analytical services with deep expertise in oncology and infectious disease including BSL-3 capabilities.

US-based early phase CRO specializing in cardiac safety (thorough QT/QTc) studies, abuse deterrent formulation, and human abuse liability studies. Operates a 120-bed clinical facility.

Indian integrated research, development, and manufacturing services company serving pharma, biotech, and nutrition companies with discovery chemistry, biology, and manufacturing capabilities.

Full-service oncology-focused CRO with 40+ years managing early-phase oncology studies for the National Cancer Institute and biopharma sponsors.

Oncology-focused CRO founded on the Mayo Clinic campus offering preclinical-to-clinical oncology development with PDX models, flow cytometry, and Phase I/II trial management.

World's leading site management organization with 90+ integrated research sites and 220+ investigators across the US, specializing in general medicine, vaccines, and infectious disease trials.

Tech-enabled next-generation CRO offering faster and lower-cost clinical trials powered by proprietary software, targeting biotech sponsors in dermatology, oncology, and ophthalmology.

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

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

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.

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.

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