Regulatory Affairs CROs in United States
44 published
44 published CROs match Regulatory Affairs in United States.
Locations in this set include United States, United Kingdom, India, Australia, Canada, and China.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Gene Therapy, Cell Therapy, and Vaccine.
Matching companies
- JSS Medical ResearchFull-service CRO with over 30 years of experience offering clinical trials, biostatistics, medical writing, and health economics services across all phases of development.
Lindus HealthLindus Health is a clinical research organization delivering end-to-end trial execution across Phase 1–2a programs with proprietary AI-driven patient recruitment, integrated site networks, and performance-based pricing. The company has completed 45+ trials with 82% on-time enrollment and operates across the US, UK, and Europe.
Lotus Clinical ResearchSpecialized CRO supporting clinical development in neuroscience and metabolic disease across all phases, with direct access to 20 wholly-owned US research sites and 400+ beds.
MedpaceFull-service CRO with 30+ years of organic growth, offering integrated clinical development services across all phases with wholly-owned central labs, bioanalytical lab, imaging core lab, and Phase I unit.- Optum Life SciencesOptum is a leading healthcare company that provides integrated medical, pharmacy, and financial services across the United States. Founded in April 2011 as a UnitedHealth Group company, Optum serves more than 120 million people through a network of doctors and care teams.
PPDPPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.
PharmaronPremier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.
Premier ResearchPremier Research is a global full-service CRO delivering clinical research and development solutions across the complete drug development lifecycle. The organization provides comprehensive capabilities spanning study design, study startup, medical affairs, biostatistics and data management, central monitoring, clinical monitoring and site management, project and risk management, safety and pharmacovigilance, quality and compliance, and medical writing.
PrimeVigilancePharmacovigilance and safety services provider offering end-to-end operations, technology-driven solutions, and specialized expertise in vaccines, CGT/ATMP, pediatric medicines, and geriatric populations.
ProRelix ResearchProRelix Research supports Phase 1–4 clinical trials across pharmaceutical, biotechnology, and medical device sectors, offering clinical trial project management, data management, and medical writing services in compliance with ICH and GCP principles across the US, India, Europe, and Australia.
Proxima Clinical ResearchProxima Clinical Research provides integrated regulatory, clinical, and quality solutions for life science companies, with expertise across device and therapeutic development pathways including IDE, 510(k), IND, NDA, and BLA submissions.
QPSQPS provides integrated contract research and clinical services spanning bioanalysis, preclinical development, and early-to-late phase clinical trials across multiple therapeutic areas including oncology, dermatology, and women's health.
QuanticateQuanticate is a biometrics CRO with 30 years of expertise in biostatistics, clinical data management, and pharmacovigilance across all clinical trial phases. The company specializes in statistical protocol design, CDISC standards compliance, and real-world data analysis to support regulatory submissions.
SPRIM PROClinical trial and strategic consulting CRO offering innovation-enabled trial solutions, digital training, patient engagement programs, and regulatory consulting across multiple therapeutic areas including oncology, CNS, cardiovascular, and rare disease.
SofpromedFull-service CRO specializing in Phase I–IV clinical trials across oncology, cardiovascular, metabolic, CNS, dermatological, infectious, and respiratory diseases, with global trial management capabilities and expertise in rare tumor research.
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.
TFS HealthScienceGlobal mid-size CRO specializing in dermatology, internal medicine, neuroscience, oncology, and ophthalmology with Phase I-IV clinical development, real-world evidence studies, and flexible resourcing solutions across 600+ experts in Europe, North America, and Australia.
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.
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