Health Canada-Experienced CROs

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.

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

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.

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

Mid-size global CRO under ALTEN Group formed by integrating Cmed and Larix, with deep oncology, rare disease, and cell/gene therapy clinical trial expertise across the US and Europe.

Canadian specialty CRO focused exclusively on gastrointestinal disease clinical trials with proprietary central reading and histopathology services for IBD and liver disease.

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.

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.

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.

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

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

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.

Dr. Reddy's wholly-owned integrated CRO and CDMO for small molecules and biologics, combining 650+ Indian scientists with GMP manufacturing in the UK, Mexico, 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.

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

Miami-based full-service CRO specialising in complex and rare disease clinical trials with deep regulatory expertise for accelerated and breakthrough therapy designations.

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

Regulatory affairs and clinical development consultancy providing full-service FDA/EMA submission support, pharmacovigilance, and clinical trial management for small pharma and biotech.

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

Full-service, technology-enabled oncology-focused CRO serving biotechnology and pharmaceutical companies across all clinical phases from Wilmington, Delaware.

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

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

North America's largest integrated research organization with 40+ wholly owned clinical sites across Canada and the US, conducting Phase I-IV trials across 35+ therapeutic areas.

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.

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

Mid-size US CRO providing full-service Phase I-IV clinical trial management with expertise in oncology, rare disease, and CNS across 50+ countries.

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

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

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.

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.

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

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.

Employee-owned Canadian scientific and regulatory toxicology consultancy with 35+ years advising FDA, EMA, and Health Canada submissions for pharma, biotech, and chemical companies.

Clinical operations arm of the former inVentiv Health (now Syneos Health) providing Phase I-IV trial management with particular expertise in dermatology and CNS therapeutic areas.

Canadian CRO providing Phase II-IV clinical trial management, real-world evidence studies, and health economics consulting with 30+ years of experience in respiratory, rheumatology, and dermatology.

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.

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

Canadian full-service CRO specialising in clinical trials and regulatory support for nutraceutical, cannabis, and natural health product industries.

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.

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

Mid-size CRO acquired by IQVIA providing boutique-level clinical development services with deep therapeutic expertise in oncology, CNS, and rare disease for small-to-mid-size biotech sponsors.

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 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.

Regulatory affairs and medical writing CRO providing IND/NDA/BLA preparation, regulatory strategy, and clinical documentation support for pharmaceutical and biotech companies.

Mid-size full-service global CRO offering Phase I-IV clinical trial management with strong coverage across emerging markets in Africa, Latin America, and Eastern Europe.

Canadian full-service CRO providing clinical research services from Phase I through Phase IV with particular expertise in bioequivalence studies and pharmacokinetic trials.

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.

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

Award-winning specialist biometrics CRO headquartered in London, providing biostatistics, statistical programming, data management, and analytics to global pharma, biotech, and device 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.

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 founded on biostatistics and data science excellence, supporting Phase I-IV trials across rare disease, immunology, and ophthalmology from Research Triangle Park.

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

India's original CRO founded in 1996 providing clinical trial operations, FSP services, data management, medical writing, biostatistics and pharmacovigilance across global programs.

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

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

Full-service boutique CRO with a purpose-built MHRA-accredited Phase I unit in South Wales. Specializes in early-phase clinical pharmacology, oncology, rare diseases, and respiratory conditions through to Phase III.

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

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.

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

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.

Specialized biometrics and regulatory CRO providing biostatistics, data management, medical writing, and regulatory strategy for pharmaceutical and biotech companies seeking FDA and EMA approvals.

Leading provider of clinical trial solutions including IRB/ethics review, site performance optimization, data analytics, and clinical trial management services for the pharmaceutical industry.

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.