--- title: Regulatory Affairs CROs path: /services/regulatory-affairs companies_count: 107 --- # Regulatory Affairs CROs 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 - [Accelera Srl](/companies/accelera) - Europe-based preclinical CRO specializing in GLP-compliant toxicology, safety assessment, and efficacy testing for small molecules and biologics, with AAALAC accreditation and integrated translational research capabilities. - [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. - [Acromion Gmbh](/companies/acromion-gmbh) - European full-service CRO supporting clinical development from Phase I to IV and non-interventional studies, with expertise in clinical monitoring, data management, biostatistics, medical writing, and regulatory affairs. - [Advanced Clinical](/companies/advancedclinical) - Global CRO and FSP provider with 25+ years of experience delivering integrated clinical research solutions across North America, Europe, LATAM, and APAC. - [Aliri Bioanalysis](/companies/aliribio) - Bioanalytical CRO specializing in PK/PD, biomarker, and spatial imaging services across discovery through Phase 3 clinical trials, with 20+ years of regulatory expertise. - [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. - [Alturas Analytics](/companies/alturasanalytics) - GLP-compliant bioanalytical CRO specializing in LC-MS/MS solutions for preclinical and clinical research, IND submissions, and new drug applications. - [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. - [Aroga Biosciences, Inc.](/companies/arogabio) - Full-service CRO providing regulatory writing, medical writing, quality control, regulatory operations, and submission management for biotech and pharmaceutical projects. - [Atheln, Inc.](/companies/athelnbiomed) - Atheln provides customized strategic and operational consulting across product development, CMC, nonclinical, clinical, regulatory, and commercial services for pharma, biotech, and medtech clients. - [Avion](/companies/avion) - Full-service CRO specializing in clinical trial management, advanced medical imaging, dosimetry, and data management across oncology, dermatology, and radiopharmaceutical therapies. - [Beaufort](/companies/beaufortcro) - Beaufort is a MedTech-specialized CRO offering clinical operations, regulatory strategy, and submission support tailored to device and diagnostic innovations across all therapeutic areas. - [BioAgile Therapeutics](/companies/bioagiletherapeutics) - ISO 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. - [BioBoston CRO](/companies/bioboston-cro) - BioBoston CRO delivers flexible clinical research consulting across regulatory affairs, medical writing, biostatistics, clinical data management, quality assurance, and project management for biotechnology and pharmaceutical sponsors. - [BioDuro-Sundia](/companies/bioduro-sundia) - BioDuro-Sundia is a contract research, development, and manufacturing organization (CRDMO) with 30 years of expertise providing integrated drug discovery, development, and manufacturing services from target identification through IND submission. - [BioPharma Services Inc.](/companies/biopharmaservices) - Full-service Phase 1 CRO specializing in early-stage clinical trials, bioequivalence/bioavailability studies, and human abuse potential assessments with state-of-the-art facilities in Toronto and in-house bioanalytical labs. - [Broughton Group](/companies/broughton-group) - Global CRO with over 15 years of experience in analytical testing integrated with scientific consultancy and regulatory compliance support across all stages of pharmaceutical development. - [CMIC HOLDINGS Co., Ltd.](/companies/cmicgroup) - CMIC HOLDINGS is a Japanese healthcare group whose Pharmaceutical Solutions cover consulting, non-clinical CRO, CRO, CDMO, SMO and CSO services. The group says it supports pharmaceutical companies across the value chain from non-clinical stages through post-marketing.