EU EMA Regulatory Strategy CROs in United States
18 published
18 published CROs match EU EMA Regulatory Strategy in United States.
Locations in this set include United States, United Kingdom, India, China, Australia, and Japan.
Capabilities that show up most often in this set: Vaccine, Biologics (Monoclonal Antibodies), Biologics (Other), Cell Therapy, and Gene Therapy.
Matching companies
Aragen Life SciencesGlobal 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.
BioAgilytixBioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually.
CertaraCertara 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.
ClinilabsClinilabs 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 ClinicalGlobal 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.
ExperTrialsEuropean-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.
FortreaFortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success.
ICON plcICON 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.
MedpaceFull-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.
PPDPPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.
PharmaronPremier 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 ResearchPremier 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 HealthClinical 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.
Syneos HealthGlobal CRO with 26,000+ employees offering integrated clinical development, regulatory affairs, and commercialization services. Helped develop or commercialize 96% of FDA-approved oncology drugs and 93% of EMA-authorized oncology products in the last five years.
Syngene InternationalInnovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
The Micron GroupGlobal 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.
VeranexVeranex 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.
uBriGeneuBriGene is a global leader in advanced therapy medicinal products (ATMPs), cell and gene therapy CDMO services, and analytical testing.
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