US FDA Regulatory Strategy CROs
58 published
58 published CROs match US FDA Regulatory Strategy.
Locations in this set include United States, United Kingdom, India, China, Australia, and Germany.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Cell Therapy, and Gene 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.
Aldeyra TherapeuticsBiopharmaceutical 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.
AllucentAllucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies.
Alturas AnalyticsGLP-compliant bioanalytical CRO specializing in LC-MS/MS solutions for preclinical and clinical research, IND submissions, and new drug applications.
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.
BioBoston CROBioBoston CRO delivers flexible clinical research consulting across regulatory affairs, medical writing, biostatistics, clinical data management, quality assurance, and project management for biotechnology and pharmaceutical sponsors.
BioDuro-SundiaBioDuro-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.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.
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.
CovarsaDxCovarsaDx provides full-service clinical research, regulatory consulting, and quality assurance for IVD and medical device trials, with expertise in FDA 510(k), De Novo, and PMA pathways.
Critical Path InstituteCritical Path Institute convenes pharmaceutical, government, patient, and academic organizations to optimize drug and medical product development through collaborative consortia, regulatory science initiatives, and clinical trial design optimization.
CuravitCuravit is an innovation CRO specializing in decentralized and virtual clinical trials, offering a comprehensive suite of CRO services from study design through FDA submission with a proprietary Virtual Clinical Site platform.
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