EU EMA Regulatory Strategy CROs
36 published
36 published CROs match EU EMA Regulatory Strategy.
Locations in this set include United States, United Kingdom, China, India, Australia, and France.
Capabilities that show up most often in this set: Biologics (Other), Vaccine, Small Molecule, Biologics (Monoclonal Antibodies), and Cell Therapy.
Matching companies
AccelsiorsFull-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.
Acromion GmbhEuropean full-service CRO supporting clinical development from Phase I to IV and non-interventional studies, with expertise in clinical monitoring, data management, biostatistics, medical writing, and regulatory affairs.
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.
Atheln, Inc.Atheln provides customized strategic and operational consulting across product development, CMC, nonclinical, clinical, regulatory, and commercial services for pharma, biotech, and medtech clients.
BioAgilytixBioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually.
Broughton GroupGlobal CRO with over 15 years of experience in analytical testing integrated with scientific consultancy and regulatory compliance support across all stages of pharmaceutical development.
CMIC HOLDINGS Co., Ltd.CMIC HOLDINGS is a Japanese healthcare group whose Pharmaceutical Solutions cover consulting, non-clinical CRO, CRO, CDMO, SMO and CSO services. The group says it supports pharmaceutical companies across the value chain from non-clinical stages through post-marketing.
CaidyaCaidya is a global, full-service CRO delivering personalized clinical development solutions across all phases of clinical research.
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.
CitelineCiteline provides clinical trial intelligence, planning, feasibility, patient engagement, and regulatory compliance solutions to pharmaceutical sponsors. The platform delivers benchmarking across 400k+ trials, site selection, protocol optimization, and disclosure management services.
ClarioClario 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.
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.
IQVIAIQVIA is a global life sciences and healthcare company providing data, expertise, AI, analytics, and technology solutions to support clinical development and improve patient outcomes.
LabcorpLabcorp 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.
MDx CROFull-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.
MMS HoldingsData-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.
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