--- title: CROs offering Regulatory Affairs with Small Molecule path: /explore/regulatory-affairs/small-molecule companies_count: 46 --- # CROs offering Regulatory Affairs with Small Molecule 46 published CROs match Regulatory Affairs and Small Molecule. Locations in this set include United States, United Kingdom, India, China, Canada, and France. Capabilities that show up most often in this set: Clinical Operations, Phase II Clinical Trials, Phase I Clinical Trials, Data Management & eClinical, and Medical Writing. ## 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. - [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. - [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. - [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. - [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. - [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. - [ChemPartner](/companies/chempartner) - Global 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. - [Clario](/companies/clario) - Clario 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. - [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. - [ICBio](/companies/icbiocro) - ICBio 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 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.