Regulatory Affairs CROs in India
19 published
19 published CROs match Regulatory Affairs in India.
Locations in this set include India, United States, United Kingdom, Australia, Poland, and Bulgaria.
Capabilities that show up most often in this set: Small Molecule, Vaccine, Cell Therapy, Gene Therapy, and Biologics (Other).
Matching companies
Aragen Life SciencesGlobal CRDMO partner offering integrated discovery-to-commercialization services across small molecules and biologics, with 4000+ scientists and R&D/manufacturing campuses in Asia, North America, and Europe.
BioAgile TherapeuticsISO 9001:2015-certified CRO offering end-to-end clinical research services including Phase I–IV trials, medical writing, biostatistics, data management, and regulatory support across pharmaceuticals, nutraceuticals, devices, and biotech.- 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.
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.
ICBioICBio is a Bengaluru-based CRO offering bioavailability/bioequivalence studies, phase II–IV clinical trials, and LC-MS/MS bioanalysis. The excerpts cite regulatory approvals from DCGI-CDSCO, ANVISA, and EMA.
ICON plcICON is a global clinical research organization providing full-service drug development and clinical trial solutions across early phase through post-marketing, including clinical operations, bioanalytical labs, cardiac safety, medical imaging, and regulatory affairs.
Innovate ResearchIndian CRO providing end-to-end clinical trial services (Phase I–IV), regulatory support, medical writing, biostatistics, data management, and biospecimen procurement across pharmaceuticals, biologics, medical devices, and nutraceuticals.- 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.
Krescent Medical ResearchFull-service preclinical and clinical CRO supporting pharmaceutical, biotechnology, and medical device companies with trial design, site selection, data management, statistical analysis, and medical writing across Asia-Pacific.
PI Health SciencesPI Health Sciences is an integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with R&D and manufacturing locations in Europe and India.
PPDPPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.
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.
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.
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.
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.
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.
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