US FDA Regulatory Strategy CROs in United States
27 published
27 published CROs match US FDA Regulatory Strategy in United States.
Locations in this set include United States, United Kingdom, India, Australia, China, and Germany.
Capabilities that show up most often in this set: Biologics (Other), Small Molecule, Vaccine, Gene Therapy, and Biologics (Monoclonal Antibodies).
Matching 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.
BioAgilytixBioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually.
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.
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.- 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.
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.
Innovate ResearchIndian CRO providing end-to-end clinical trial services (Phase I–IV), regulatory support, medical writing, biostatistics, data management, and biospecimen procurement across pharmaceuticals, biologics, medical devices, and nutraceuticals.
Lotus Clinical ResearchSpecialized CRO supporting clinical development in neuroscience and metabolic disease across all phases, with direct access to 20 wholly-owned US research sites and 400+ beds.
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.
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.
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.
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.
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