--- title: Regulatory Affairs CROs in United States path: /services/regulatory-affairs/us companies_count: 44 --- # Regulatory Affairs CROs in United States 44 published CROs match Regulatory Affairs in United States. Locations in this set include United States, United Kingdom, India, Australia, Canada, and China. Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Gene Therapy, Cell Therapy, and Vaccine. ## Matching companies - [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. - [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. - [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. - [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. - [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. - [Clarenta](/companies/comac-medical) - Clarenta (formerly Comac Medical Group) is a pan-European CRO offering full-service trial delivery and early-phase studies, including first-in-human and PK work. It runs a Phase I unit in Sofia and has depth in oncology and rare diseases. - [Clinilabs](/companies/clinilabs) - Clinilabs is the leading CNS-focused CRO with 25+ years of expertise in neurotherapeutic clinical trials, offering Phase 1–4 trial management, early-phase development, clinical research units, and MedTech device expertise across psychiatry, neurology, substance use, and rare CNS disorders. - [ERGOMED Group](/companies/ergomed) - Global, full-service CRO specializing in oncology and rare disease clinical development, with complementary pharmacovigilance and QA consulting brands. - [Emerald Clinical](/companies/emeraldclinical) - Global 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. - [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. - [ExperTrials](/companies/expertrials) - European-based full-service CRO supporting biotech and medtech companies from Phase I through Phase IV and market access, with 80+ senior clinical research associates across Europe and the USA. - [Fortrea](/companies/fortrea) - Fortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success. - [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. - [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.