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
CTI Clinical Trial and Consulting ServicesFull-service CRO founded in 1999 providing therapeutic expertise across clinical trial and consulting services to pharmaceutical and biotechnology companies.
Cadena ResearchCadena Research is a CRO specializing in preclinical development of radiopharmaceuticals, offering laboratory services, radiochemistry expertise, regulatory guidance, and scientific advisory support to accelerate drug development and approval.
CaidyaCaidya is a global, full-service CRO delivering personalized clinical development solutions across all phases of clinical research.
CelerionGlobal CRO specializing in early-phase clinical research and bioanalytical sciences with 650+ beds across 30 countries and 50+ years of experience.
CertaraCertara transforms drug development with proprietary biosimulation software, predictive modeling, and AI-driven services spanning discovery through commercialization. Serving 2,400+ biopharmaceutical companies and regulatory agencies across 70 countries, Certara's model-informed drug development (MIDD) platform accelerates clinical and regulatory decision-making.
ChemPartnerGlobal preclinical CRO with 20+ years of experience supporting drug discovery through IND submission across small molecules and biologics, with 2,000+ scientists and facilities worldwide.
CitelineCiteline provides clinical trial intelligence, planning, feasibility, patient engagement, and regulatory compliance solutions to pharmaceutical sponsors. The platform delivers benchmarking across 400k+ trials, site selection, protocol optimization, and disclosure management services.
ClarentaClarenta (formerly Comac Medical Group) is a pan-European CRO offering full-service trial delivery and early-phase studies, including first-in-human and PK work. It runs a Phase I unit in Sofia and has depth in oncology and rare diseases.
ClarioClario provides comprehensive clinical trial endpoint solutions spanning cardiac safety, eCOA, medical imaging, respiratory, and precision motion analysis, supporting approximately 70% of FDA and EMA novel drug approvals over the past decade.
ClinActis Pte LtdFull-service CRO delivering clinical trial services across Asia Pacific, with 50+ years of cumulative experience managing Phase I–IV trials and expertise in oncology, cardiovascular, CNS, and infectious disease indications.- Clinical Research Network India Pvt. Ltd.Clinical Research Organization offering Phase I–IV clinical trials, pharmacovigilance, medical writing, regulatory affairs, and data management services with 15+ years of experience across cardiology, oncology, vaccines, and medical devices.
ClinilabsClinilabs is the leading CNS-focused CRO with 25+ years of expertise in neurotherapeutic clinical trials, offering Phase 1–4 trial management, early-phase development, clinical research units, and MedTech device expertise across psychiatry, neurology, substance use, and rare CNS disorders.
CovarsaDxCovarsaDx provides full-service clinical research, regulatory consulting, and quality assurance for IVD and medical device trials, with expertise in FDA 510(k), De Novo, and PMA pathways.
Critical Path InstituteCritical Path Institute convenes pharmaceutical, government, patient, and academic organizations to optimize drug and medical product development through collaborative consortia, regulatory science initiatives, and clinical trial design optimization.
CytelCytel provides data science and advanced analytics solutions across the drug development lifecycle, from discovery through commercialization, including clinical trial design, adaptive trial strategies, real-world evidence, and regulatory support.
DatavantDatavant operates the largest health data network in the U.S., providing secure, compliant data connectivity and real-world data solutions to life sciences, health plans, providers, and legal/insurance organizations.
ERGOMED GroupGlobal, full-service CRO specializing in oncology and rare disease clinical development, with complementary pharmacovigilance and QA consulting brands.
Emerald ClinicalGlobal clinical research organization with 25+ years of expertise, headquartered in Singapore with operations across Asia-Pacific, EMEA, and the Americas. Specializes in renal, oncology, cardiovascular, and early-phase research with deep scientific leadership and proven operational excellence.
Emery PharmaFull-service CRO delivering analytical, bioanalytical, and microbiology services across small molecules, biologics, gene therapy, and botanical drugs from discovery through clinical development.- Ergomed Clinical ResearchErgomed is a specialized CRO with 25+ years of experience delivering oncology, rare disease, and complex clinical trial solutions across all phases globally, backed by a team of 100+ MDs and PhDs.
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