CROs offering US FDA Regulatory Strategy (CRO)

Matching companies

• Accelsiors

  Full-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 Therapeutics

  Biopharmaceutical 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.

• Allucent

  Allucent is a full-service CRO specializing in clinical development solutions for small and mid-sized biotech companies.

• Alturas Analytics

  GLP-compliant bioanalytical CRO specializing in LC-MS/MS solutions for preclinical and clinical research, IND submissions, and new drug applications.

• Aragen Life Sciences

  Global 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.

• BioAgilytix

  Bioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually.

• BioBoston CRO

  BioBoston 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-Sundia

  BioDuro-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 Group

  Global 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 contract research and manufacturing organization providing end-to-end pharmaceutical solutions from non-clinical through post-marketing phases, including consulting, CRO, CDMO, and SMO services.

• Caidya

  Caidya is a global, full-service CRO delivering personalized clinical development solutions across all phases of clinical research.

• Certara

  Certara 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.

• Citeline

  Citeline 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.

• Clario

  Clario 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.

• Clinilabs

  Clinilabs 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.

• CovarsaDx

  CovarsaDx 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 Institute

  Critical 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.

• Curavit

  Curavit 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.

• Emerald Clinical

  Global 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 Research

  Ergomed 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.

• Fortrea

  Fortrea is a leading CRO advancing clinical trials through patient-focused clinical solutions that accelerate clinical development and drive trial success.

• Frontage Laboratories

  Global 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 plc

  ICON 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.

• IQVIA

  IQVIA is a global life sciences and healthcare company providing data, expertise, AI, analytics, and technology solutions to support clinical development and improve patient outcomes.

• Innovate Research

  Indian 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.

• Labcorp

  Labcorp 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.

• Lotus Clinical Research

  Specialized 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.

• MMS Holdings

  Data-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.

• Medpace

  Full-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.

• Novotech

  Global full-service CRO specializing in early-phase and oncology trials across 50+ countries, with expertise in cardiovascular, cell and gene therapy, and radiopharmaceutical development.

• PPD

  PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific.

• Parexel

  Parexel 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.

• PharmaLegacy Laboratories

  Preclinical CRO with over 1,500 validated in vivo efficacy models spanning 100+ indications in oncology, immunology, inflammation, and bone disease. AAALAC-accredited vivarium with capacity for 30,000 rodents and 350 non-human primates supports IND filings to FDA and CFDA.

• Pharmaron

  Premier 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 Research

  Premier 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.

• Proone Labs

  Proone Labs provides preclinical pharmacology, drug discovery, and regulatory support services to biotech startups, traditional pharma, and in-silico companies. The team has delivered 30+ assays, 50+ cell lines, and supported 4 FDA drug approvals across multiple therapeutic areas.

• Protheragen

  Specialized preclinical CRO dedicated to obesity research, offering comprehensive animal models, pharmacokinetic/pharmacodynamic studies, bioanalysis, and safety assessment for anti-obesity drug development.

• Proxima Clinical Research

  Proxima 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.

• QPS

  QPS 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 PRO

  Clinical 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 GmbH

  Sacura 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 Oncology

  Full-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 Health

  Clinical 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-Orion

  Full-service CRO delivering clinical trial management across early to late phases, with specialist expertise in rare diseases and oncology.

• Syneos Health

  Global 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 International

  Innovation-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 Group

  Global 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.