--- title: CROs offering Regulatory Affairs with Gene Therapy path: /explore/regulatory-affairs/gene-therapy companies_count: 33 --- # CROs offering Regulatory Affairs with Gene Therapy 33 published CROs match Regulatory Affairs and Gene Therapy. Locations in this set include United States, India, United Kingdom, China, Australia, and Canada. Capabilities that show up most often in this set: Clinical Operations, Phase II Clinical Trials, Phase IV / Post-Marketing, Medical Writing, and Biostatistics & Statistical Programming. ## Matching companies - [Accelsiors](/companies/accelsiors) - Full-service CRO providing clinical trial management, regulatory consulting, pharmacovigilance, biostatistics, and medical writing across 40+ countries with AI-secure eClinical systems and patient-centered trial design. - [Allucent](/companies/allucent) - Allucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies. - [Altasciences](/companies/altasciences) - Mid-size early phase CRO/CDMO in Canada and the U.S. offering preclinical safety testing, clinical pharmacology (Phase I–II), bioanalysis, research services, and manufacturing with integrated capabilities. - [Amador Bioscience](/companies/amadorbioscience) - Amador Bioscience provides bioanalysis and biomarker services, including LCMS, immunoassays, flow cytometry, and immunogenicity testing, alongside clinical pharmacology modeling and regulatory affairs support. Its labs are GLP compliant, and its teams work across the US, China, and Europe. - [Aragen Life Sciences](/companies/aragen) - Global 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. - [CTI Clinical Trial and Consulting Services](/companies/ctifacts) - Full-service CRO founded in 1999 providing therapeutic expertise across clinical trial and consulting services to pharmaceutical and biotechnology companies. - [Caidya](/companies/caidya) - Caidya is a global, full-service CRO delivering personalized clinical development solutions across all phases of clinical research. - [Celerion](/companies/celerion) - Global CRO specializing in early-phase clinical research and bioanalytical sciences with 650+ beds across 30 countries and 50+ years of experience. - [Certara](/companies/certara) - Certara 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. - [Clinical Research Network India Pvt. Ltd.](/companies/crnindia) - 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. - [Emery Pharma](/companies/emerypharma) - Full-service CRO delivering analytical, bioanalytical, and microbiology services across small molecules, biologics, gene therapy, and botanical drugs from discovery through clinical development. - [Ergomed Clinical Research](/companies/medsource) - Ergomed 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. - [Fortrea](/companies/fortrea) - Fortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success. - [Frontage Laboratories](/companies/frontagelab) - Global pharmaceutical development organization offering integrated drug discovery, preclinical safety/toxicology, DMPK, bioanalytical, and clinical trial services across 28 sites with 2,200 employees and 200+ FDA inspections. - [ICON plc](/companies/iconplc) - ICON 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. - [IQVIA](/companies/iqvia) - IQVIA is a global life sciences and healthcare company providing data, expertise, AI, analytics, and technology solutions to support clinical development and improve patient outcomes. - [Labcorp](/companies/labcorp) - Labcorp is a global life sciences and healthcare company providing diagnostic testing, drug development, nonclinical research, central laboratory services, and real-world data solutions to healthcare providers, health systems, and biopharma companies. - [Medpace](/companies/medpace) - Full-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. - [Novotech](/companies/novotech-cro) - Global full-service CRO specializing in early-phase and oncology trials across 50+ countries, with expertise in cardiovascular, cell and gene therapy, and radiopharmaceutical development. - [PPD](/companies/ppd) - PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.