Regulatory Affairs CROs
107 published
107 published CROs match Regulatory Affairs.
Locations in this set include United States, United Kingdom, India, Canada, Australia, and China.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Gene Therapy, Cell Therapy, and Vaccine.
Matching companies
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.
ResolveMass Laboratories Inc.Canadian CRO and CDMO specializing in polymer synthesis, peptide characterization, and advanced analytical services for drug delivery and pharmaceutical development. FDA-registered and ISO 9001:2015 certified, serving North American pharmaceutical and biotech companies.
SMO India Clinical Research Pvt LtdCDSCO-registered CRO with 25+ years of clinical trial experience across Phase I–IV studies in India. Specializes in site management, clinical operations, and regulatory affairs across diverse therapeutic areas.
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.
Sacura GmbHSacura specializes in clinical trial management and regulatory support for biotech and pharma companies, with expertise in complex international studies and late-stage preclinical-to-market development planning.
SanaClisGlobal full-service CRO founded in 2000, offering end-to-end clinical trial support across all phases with integrated clinical supply chain management, logistics, and strategic sourcing capabilities.
SciQuus OncologyFull-service CRO specializing in oncology clinical trials, from preclinical IND-enabling studies through Phase I–III trial management, with expertise in First-in-Human studies for new cancer therapies.
SelvitaSelvita is an integrated drug discovery and development service provider offering comprehensive solutions from target validation through preclinical candidate nomination and clinical manufacturing, with expertise in small molecules, antibodies, and protein degraders.
Simbec-OrionFull-service CRO delivering clinical trial management across early to late phases, with specialist expertise in rare diseases and oncology.
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.
SteerOn ResearchDiscovery chemistry CRO offering computational, medicinal, synthetic, and analytical chemistry services alongside regulatory support including PDE/OEL assessments, genotoxicity evaluations, and pharmacovigilance for pharmaceutical and biotech clients.
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.
TigermedLeading global CRO providing end-to-end clinical trial services, preclinical development, medical device and IVD trials, regulatory affairs, and real-world evidence studies across 180+ offices serving 4,000+ customers.
Trinity Life SciencesTrinity Life Sciences is a strategic, tech-enabled commercialization company that empowers pharma, biotech, and medtech organizations to advance the development, launch, and optimization of new medical innovations.
V2 Clinical Inc.V2 Clinical is a clinical consulting CRO offering expert services in clinical operations, regulatory support, medical writing, data management, biostatistics, and quality assurance to biotech companies.
VIRSCIOVirscio is a preclinical CRO offering non-human primate studies, histopathology, and molecular biology services. It supports IND-enabling efficacy, safety, and PK/PD programs in CNS, ophthalmology, and cardiometabolic areas.
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