--- title: CROs offering US FDA Regulatory Strategy with Small Molecule path: /explore/regulatory-us-fda/small-molecule companies_count: 33 --- # CROs offering US FDA Regulatory Strategy with Small Molecule 33 published CROs match US FDA Regulatory Strategy and Small Molecule. Locations in this set include United States, United Kingdom, China, India, Australia, and Germany. Capabilities that show up most often in this set: Regulatory Affairs, Clinical Operations, Phase II Clinical Trials, Biostatistics & Statistical Programming, and Phase III Clinical Trials. ## 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. - [Aldeyra Therapeutics](/companies/aldeyra) - Biopharmaceutical company developing immunomodulatory therapies for immune-mediated ocular and systemic diseases, with late-stage clinical candidates targeting dry eye disease, allergic conjunctivitis, and retinal conditions. - [Allucent](/companies/allucent) - Allucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies. - [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. - [BioAgilytix](/companies/bioagilytix) - Bioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually. - [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. - [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. - [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. - [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. - [Innovate Research](/companies/innovate-research) - Indian 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. - [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. - [MMS Holdings](/companies/mmsholdings) - Data-focused CRO providing full-spectrum biometrics, regulatory submissions, safety & risk management, and therapeutic expertise across oncology, CNS, rare diseases, and psychedelics. Named Best Specialist CRO at the Scrip Awards with zero refusals to file on 50+ marketing applications in five years. - [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. - [PPD](/companies/ppd) - PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.