PMDA-Experienced CROs

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

Global leader in providing preclinical and clinical laboratory services. Charles River offers early-stage discovery, safety assessment, and clinical support services to pharmaceutical and biotech companies worldwide.

Global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. ICON specializes in clinical research with operations across 53 countries.

Formerly Covance, Labcorp Drug Development provides comprehensive drug development services from early discovery through post-approval. One of the world's largest CROs with extensive nonclinical and clinical capabilities.

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.

A leading global contract research organization acquired by Thermo Fisher Scientific. PPD provides comprehensive clinical development services including laboratory, data management, and regulatory services.

Global biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities. Syneos offers end-to-end solutions from Phase I through product launch and beyond.

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.

Japanese CRO subsidiary providing clinical monitoring, data management, and pharmacovigilance services specializing in small-to-mid-size pharma and biotech sponsors across Asia.

Global CDMO with 30+ years delivering development and manufacturing for biologics, cell therapies, viral vectors, and mRNA across US, European, and Asian facilities.

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

Hyderabad-based mid-size CRO operating across India, the Philippines, Thailand, Vietnam, and the Middle East, providing Phase I-IV clinical trial services and regulatory affairs.

Italian preclinical CRO providing GLP safety pharmacology, general and genetic toxicology, DMPK, and bioanalytical services from Nerviano (Milan) facilities.

Munich-headquartered European CDMO providing development and manufacturing of solid oral dosage forms, capsules, and effervescent tablets with 12 GMP manufacturing sites across Europe.

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

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

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

UK nonclinical safety CRO founded by former AstraZeneca scientists, specializing in integrated toxicology and ion channel electrophysiology studies for regulatory drug safety assessment.

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.

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.

Australian full-service CRO providing Phase 1–3 clinical trial management with expertise in biotech-focused programs. Known for the Australian Clinical Trial Notification (CTN) regulatory pathway advantage.

Osaka-based clinical CRO specializing in medical device and diagnostic clinical trials in Japan, providing regulatory consulting, site management, and data management services under PMDA guidelines.

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

South Korea's first CRO founded in 1997, providing comprehensive Phase I-IV clinical development solutions including regulatory affairs, data management, pharmacovigilance and medical translation.

South Korean CRO specializing in clinical trial management and data services for pharmaceutical companies developing products for both Korean and global regulatory submissions.

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

Japan's largest independent CRO providing end-to-end pharmaceutical development services including clinical operations, data management, regulatory affairs, and post-marketing surveillance across Asia.

China-based global CRO providing full clinical development services from Phase I through IV with strong site networks across China, Korea, and Southeast Asia.

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

Celerion's clinical pharmacology facility in Lincoln, Nebraska, providing early-phase clinical trials, BA/BE studies, and cardiac safety testing with a 200+ bed Phase I unit.

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

Biosimulation and regulatory science company providing model-informed drug development, regulatory science consulting, and software solutions for the pharmaceutical industry.

UK-headquartered global mid-size CRO (now part of LabCorp/Covance) with deep expertise in oncology, rare diseases, and paediatric clinical trials across 30+ countries.

Mid-size global CRO acquired by Labcorp providing clinical development services from Phase I through Phase IV with operations across Europe, Asia, and the Americas.

Global clinical trial technology and endpoint services company providing cardiac safety (ECG), respiratory, imaging, patient-reported outcomes, and clinical event adjudication for pharma and biotech sponsors.

Singapore-founded full-service CRO with operations across 12 Asia-Pacific markets, offering clinical trial management, regulatory affairs and data services.

Global full-service CRO founded in 1995 with strong Asia-Pacific and European presence, expanded via acquisition of CROMSOURCE for deeper European clinical operations.

Glasgow-founded, India-expanded full-service CRO providing clinical trial management, site management, and regulatory services across Asia-Pacific, Europe, and North America.

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

Technology-enabled mid-size clinical CRO offering Phase I-IV development services with particular strength in oncology, rare disease, and CNS therapeutic areas.

New Jersey-based mid-size CRO and FSP provider offering clinical operations, data management, and regulatory services across 40+ countries.

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

Labcorp's early development and Phase 1 clinical unit operating dedicated clinical pharmacology facilities. Provides first-in-human, bioavailability/bioequivalence, and thorough QT studies.

Labcorp Drug Development's UK preclinical facility providing GLP toxicology, safety pharmacology, and reproductive toxicology studies from Harrogate, North Yorkshire.

Labcorp Drug Development's Japanese operations providing preclinical safety assessment, bioanalytical services, and clinical trial support for regulatory submissions to PMDA and other Asian regulatory agencies.

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

Singapore-based global CRO consulting organisation assisting clients from clinical development through commercialisation with a focus on Asia-Pacific market access.

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.

Biostatistics-focused CRO and software company pioneering adaptive trial design, group sequential methods, and clinical trial simulation for pharma and biotech.

South Korean full-service CRO providing clinical development services from Phase I through post-marketing with bioanalytical capabilities and strong ties to Korean academic medical centers.

South Korea's largest clinical CRO and Tigermed subsidiary, delivering full-scope clinical services with 1,200+ successful projects across pharmaceuticals, biotech, and medical devices.

Japanese CRO group providing clinical development, data management, biostatistics, and regulatory affairs services across Japan, China, Korea, and Southeast Asia.

Global full-service CRO specializing in oncology, rare disease, and complex clinical trials across all development phases, with 2,900+ clinical research professionals operating in 100+ countries.

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.

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

Contract research organization spun off from Labcorp in 2023. Provides Phase 1–4 clinical development services, patient access solutions, and regulatory consulting globally.

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

Asia-Pacific focused full-service CRO providing clinical trial management, data management, and biostatistics services with particular expertise in cardiovascular, renal, and diabetes trials.

Munich-based mid-size CRO providing Phase I-IV clinical trial management, regulatory consulting, pharmacovigilance, and medical affairs across Europe and Asia.

ICON's Australian operations leveraging Australia's CTN scheme for rapid Phase I trial initiation, supporting multinational sponsors with early-phase development in the APAC region.

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

ICON's Japanese operations providing full-service clinical development for pharmaceutical companies conducting trials in Japan and supporting PMDA regulatory submissions.

Global clinical research and health data analytics company formed from the merger of IMS Health and Quintiles. Offers end-to-end clinical development, real-world evidence, and technology solutions.

IQVIA's Indian operations providing comprehensive clinical development, regulatory consulting, and healthcare analytics services for pharmaceutical companies across South Asia.

IQVIA's Japanese subsidiary providing clinical operations, real-world data analytics, regulatory strategy and technology solutions with one of the largest clinical operations teams in Japan.

Chinese preclinical CRO providing GLP-compliant safety evaluation, pharmacokinetics, efficacy studies, and drug metabolism studies with comprehensive NHP and rodent capabilities.

Therapeutically specialized CRO focused on CNS, cardio-metabolic, renal, and rare disease trials, providing end-to-end CRO and SMO services across 39 countries with 220,000+ subjects enrolled.

Kobe-based Japanese CRO and research institute specializing in preclinical safety assessment, pharmacology and drug metabolism studies with GLP-accredited facilities.

Cincinnati-based full-service CRO providing Phase I-IV clinical trial management, clinical pharmacology, and regulatory consulting services for pharmaceutical and biotech sponsors worldwide.

South Korean CRO providing Phase I-IV clinical development, bioanalytical services, and regulatory consulting with particular expertise in simultaneous MFDS-FDA-EMA regulatory submissions.

Seoul-based full-service Korean CRO with 400 clinical trial experts and experience across 1,600+ studies including 180+ global multi-center trials.

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

Japanese full-service CRO with global operations providing clinical development from early phase through post-marketing with deep oncology and CNS expertise across Asia, Europe, and the US.

Global CRO with nearly 1,000 employees covering 30+ countries, providing full-spectrum multilingual clinical development from early phase through post-approval in oncology and CNS.

Japanese digital health and clinical research subsidiary of M3 Inc., leveraging its physician panel of 300,000+ doctors for clinical trial site identification and recruitment in Japan.

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.

Vietnam's dedicated CRO/SMO founded by Japan's SRD Group, applying Japanese GCP expertise to support clinical trials at Vietnamese research hospitals.

Chinese integrated drug discovery and development CRO providing medicinal chemistry, ADME/PK, pharmacology, toxicology, and CMC services from Shanghai operations.

Pioneer Japanese CRO founded in 1982 providing one-stop pharmaceutical development services from early-phase through post-marketing activities in Japan and Asia.

Scientifically-driven, global, full-service clinical CRO providing Phase I-IV clinical development services. Medpace is known for its therapeutic expertise and operational efficiency.

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.

Tokyo-based CRO and CDMO providing contract manufacturing of injectable formulations, lyophilized products, and sterile fills for Japanese and international pharmaceutical clients.

Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.

Clinical pharmacology consulting firm specializing in PK/PD modeling, dose optimization, biosimilar development strategy, and regulatory science for pharmaceutical and biotech companies.

Global CRO acquired by ICON in 2021. Provides full-service clinical development, data management, and strategic consulting across all major therapeutic areas.

Swiss full-service CRO operating in 56 countries with 3,000 staff, specializing in pivotal Phase II-III clinical trials in oncology, hematology, multiple sclerosis, and rare diseases.

Parexel's Indian operations providing clinical trial management, data management, biostatistics, and regulatory consulting for pharmaceutical companies conducting trials in India and South Asia.

Parexel's Japanese arm offering full-service clinical development, regulatory consulting and market access services with deep PMDA submission expertise.

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.

Taipei-based drug development company and CRO specializing in oncology, running Phase I-III clinical trials for new cancer therapies and out-licensing proprietary pipeline assets.

Global regulatory affairs and drug development consulting firm providing IND/NDA/MAA filing support, clinical development strategy, and pharmacovigilance services.

European regulatory affairs and pharmacovigilance services provider offering end-to-end regulatory strategy, submission management, and post-authorization compliance for pharma and biotech companies.

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

Full-service global CRO providing clinical development services across all phases with deep expertise in CNS, rare disease, and cardiovascular therapeutic areas and strong site networks.

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

One of the world's largest data-focused biometrics CROs, providing biostatistics, statistical programming, clinical data management, and medical writing without conducting clinical operations.

Global preclinical and drug discovery CRO offering the world's largest catalog of human fresh tissue assays for efficacy, ADME, and safety testing in GLP-accredited labs across the US, UK, and Japan.

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

Uppsala-based Swedish CDMO providing pharmaceutical development, manufacturing, and sterile fill-finish services with expertise in complex injectables and lyophilized products.

National clinical research coordinating body in Singapore established by A*STAR and MOH, offering study design, project management, data management, and biostatistics to pharma and academic sponsors.

Global CDMO with integrated small molecule, biologics, and gene therapy manufacturing including proprietary viral vector platforms across the US, Europe, and Asia.

Japanese preclinical CRO providing GLP safety assessment, pharmacokinetics, and toxicology studies with specialized NHP and inhalation toxicology capabilities from facilities in Japan and the US.

Japan's pioneering CRO founded in 1957 offering non-clinical safety evaluation including NHP studies, clinical Phase I-IV development, and a proprietary nasal drug delivery platform.

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.

Japanese CRO established in 1989 offering full CRO and SMO services in Japan and Vietnam through its Asia Clinical Trial Support Alliance network.

Hyderabad-based Indian CDMO providing integrated drug discovery, development, and manufacturing services with capabilities spanning medicinal chemistry through commercial API supply.

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.

Denmark-based GLP preclinical CRO offering safety pharmacology, general toxicology, reproductive toxicology, and ADME studies, known for rodent and non-rodent capabilities including minipig models.

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.

Singapore's national academic clinical research organization supporting investigator-initiated and industry-sponsored clinical trials across Southeast Asia with strong oncology expertise.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities to accelerate customer success from Phase I through product launch.

Syneos Health's Korean operations providing full-service clinical development support for Korean and global pharmaceutical companies conducting trials in South Korea and APAC markets.

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

Mid-size global CRO with nearly 700 professionals across 50 countries, specializing in oncology, rare disease, and complex clinical programs with particular strength in dermatology and CNS.

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

China's largest independent CRO providing comprehensive clinical development services from preclinical through post-marketing with operations across China, Asia, and globally.

Medical writing and regulatory consulting CRO providing clinical study reports, investigator brochures, CTD modules, and submission documents for FDA and EMA regulatory filings.

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.

Clinical division of WuXi AppTec providing end-to-end Phase I-IV clinical trial services across China and Asia with expertise in NMPA, FDA and EMA 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.

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

South Korean pharmaceutical research institute providing preclinical safety assessment, ADME/PK studies, and efficacy testing from GLP-certified facilities in Seoul.