US FDA Regulatory Strategy CROs in United States
27 published
27 published CROs match US FDA Regulatory Strategy in United States.
Locations in this set include United States, United Kingdom, India, Australia, China, and Germany.
Capabilities that show up most often in this set: Biologics (Other), Small Molecule, Vaccine, Gene Therapy, and Biologics (Monoclonal Antibodies).
Matching companies
Syneos HealthGlobal CRO with 26,000+ employees offering integrated clinical development, regulatory affairs, and commercialization services. Helped develop or commercialize 96% of FDA-approved oncology drugs and 93% of EMA-authorized oncology products in the last five years.
Syngene InternationalInnovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
The Micron GroupGlobal CRO delivering clinical trial management, regulatory consultancy, data management, and medical writing for biotech, pharma, and medical device companies across Phase I–IV studies and real-world evidence programs.
Therapeutics Inc.Dermatology-focused CRO providing integrated, turnkey solutions across non-clinical, clinical, and regulatory development from concept to commercialization.
Velocity Clinical ResearchIntegrated clinical research site organization operating 60+ sites across the U.S. and Europe, supporting trials that contributed to 61 FDA-approved products since 1986.
VeranexVeranex is an Innovation CRO uniting design, preclinical, clinical, regulatory, and market-access expertise for medical devices and diagnostics. The company accelerates development from concept through commercialization with integrated cross-disciplinary teams across 15 international hubs.
uBriGeneuBriGene is a global leader in advanced therapy medicinal products (ATMPs), cell and gene therapy CDMO services, and analytical testing.
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