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
Proxima Clinical ResearchProxima Clinical Research provides integrated regulatory, clinical, and quality solutions for life science companies, with expertise across device and therapeutic development pathways including IDE, 510(k), IND, NDA, and BLA submissions.
QPSQPS provides integrated contract research and clinical services spanning bioanalysis, preclinical development, and early-to-late phase clinical trials across multiple therapeutic areas including oncology, dermatology, and women's health.
ResolveMass Laboratories Inc.Canadian CRO and CDMO specializing in polymer synthesis, peptide characterization, and advanced analytical services for drug delivery and pharmaceutical development. FDA-registered and ISO 9001:2015 certified, serving North American pharmaceutical and biotech companies.
SPRIM PROClinical trial and strategic consulting CRO offering innovation-enabled trial solutions, digital training, patient engagement programs, and regulatory consulting across multiple therapeutic areas including oncology, CNS, cardiovascular, and rare disease.
Sacura GmbHSacura specializes in clinical trial management and regulatory support for biotech and pharma companies, with expertise in complex international studies and late-stage preclinical-to-market development planning.
SciQuus OncologyFull-service CRO specializing in oncology clinical trials, from preclinical IND-enabling studies through Phase I–III trial management, with expertise in First-in-Human studies for new cancer therapies.
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.
Simbec-OrionFull-service CRO delivering clinical trial management across early to late phases, with specialist expertise in rare diseases and oncology.
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.
Therapeutics Inc.Dermatology-focused CRO providing integrated, turnkey solutions across non-clinical, clinical, and regulatory development from concept to commercialization.
TigermedLeading global CRO providing end-to-end clinical trial services, preclinical development, medical device and IVD trials, regulatory affairs, and real-world evidence studies across 180+ offices serving 4,000+ customers.
Velocity Clinical ResearchIntegrated clinical research site organization operating 60+ sites across the U.S. and Europe, supporting trials that contributed to 61 FDA-approved products since 1986.
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.
WuXi AppTecGlobal 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.
ethica CROethica CRO is the first contract research organization in the world to achieve HRPP accreditation from three distinct accrediting bodies, specializing in medical aesthetics, dermatology, and clinical trial management with a focus on ethical excellence and participant safety.
uBriGeneuBriGene is a global leader in advanced therapy medicinal products (ATMPs), cell and gene therapy CDMO services, and analytical testing.
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