CROs offering US FDA Regulatory Strategy with Gene Therapy
25 published
25 published CROs match US FDA Regulatory Strategy and Gene Therapy.
Locations in this set include United States, China, India, United Kingdom, Australia, and Germany.
Capabilities that show up most often in this set: Regulatory Affairs, Phase II Clinical Trials, Phase III Clinical Trials, Biostatistics & Statistical Programming, and Clinical Operations.
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.
AllucentAllucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech 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.
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.- Ergomed Clinical ResearchErgomed is a specialized CRO with 25+ years of experience delivering oncology, rare disease, and complex clinical trial solutions across all phases globally, backed by a team of 100+ MDs and PhDs.
FortreaFortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success.
Frontage LaboratoriesGlobal pharmaceutical development organization offering integrated drug discovery, preclinical safety/toxicology, DMPK, bioanalytical, and clinical trial services across 28 sites with 2,200 employees and 200+ FDA inspections.
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.
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.
NovotechGlobal full-service CRO specializing in early-phase and oncology trials across 50+ countries, with expertise in cardiovascular, cell and gene therapy, and radiopharmaceutical development.
PPDPPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.
ParexelParexel is a comprehensive CRO offering end-to-end biopharmaceutical development services spanning portfolio optimization, early development, integrated clinical development, regulatory approval, and lifecycle value substantiation.
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.
ProtheragenSpecialized preclinical CRO dedicated to obesity research, offering comprehensive animal models, pharmacokinetic/pharmacodynamic studies, bioanalysis, and safety assessment for anti-obesity drug development.
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.
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.
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