--- title: US FDA Regulatory Strategy CROs in Europe path: /services/regulatory-us-fda/europe companies_count: 16 --- # US FDA Regulatory Strategy CROs in Europe 16 published CROs match US FDA Regulatory Strategy in Europe. Locations in this set include United Kingdom, United States, China, India, Australia, and Germany. Capabilities that show up most often in this set: Vaccine, Biologics (Other), Small Molecule, Biologics (Monoclonal Antibodies), and Gene Therapy. ## Matching companies - [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. - [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. - [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. - [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. - [MDx CRO](/companies/mdxcro) - Full-service CRO for IVD manufacturers, medical device companies, and precision medicine sponsors. Offers performance studies under ISO 20916 and ISO 14155, EU MDR/IVDR and FDA regulatory support, and companion diagnostic development. - [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. - [Pharmaron](/companies/pharmaron) - Premier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK. - [Premier Research](/companies/premier-research) - Premier Research is a global full-service CRO delivering clinical research and development solutions across the complete drug development lifecycle. The organization provides comprehensive capabilities spanning study design, study startup, medical affairs, biostatistics and data management, central monitoring, clinical monitoring and site management, project and risk management, safety and pharmacovigilance, quality and compliance, and medical writing. - [Signant Health](/companies/signanthealth) - Clinical trial technology and services provider with 30 years of experience supporting thousands of trials and 25% of novel drug approvals (FDA/EMA, 2021–2024). Offers eClinical solutions, protocol guidance from 50+ in-house scientists and clinicians, and global operational scale. - [Simbec-Orion](/companies/simbecorion) - Full-service CRO delivering clinical trial management across early to late phases, with specialist expertise in rare diseases and oncology. - [The Micron Group](/companies/micron-group) - Global CRO delivering clinical trial management, regulatory consultancy, data management, and medical writing for biotech, pharma, and medical device companies across Phase I–IV studies and real-world evidence programs. - [Velocity Clinical Research](/companies/velocityclinical) - Integrated clinical research site organization operating 60+ sites across the U.S. and Europe, supporting trials that contributed to 61 FDA-approved products since 1986. - [Veranex](/companies/quartesian) - Veranex is an Innovation CRO uniting design, preclinical, clinical, regulatory, and market-access expertise for medical devices and diagnostics. The company accelerates development from concept through commercialization with integrated cross-disciplinary teams across 15 international hubs. - [WuXi AppTec](/companies/wuxiapptec) - Global CRDMO platform providing integrated end-to-end contract research, development, and manufacturing services across discovery, preclinical, clinical, and commercial phases for small molecules, peptides, oligonucleotides, and biologics across 30+ countries.