CROs offering US FDA Regulatory Strategy (CRO)
US FDA Regulatory Strategy is an important service area used by sponsors to shortlist partners for specific delivery, regulatory, and execution needs. This page groups CRO organizations offering US FDA Regulatory Strategy, so you can quickly identify which teams align with your program priorities without having to scan unrelated profiles.
Use this listing as a starting point: open each profile to review scope, facility footprint, and public evidence that supports the listed capabilities. Because the directory is fit-first, the goal is not to crown one universal "best" provider, but to help you build a right-sized shortlist for your stage, geography, and quality expectations.
When you are ready to compare options, move to search and add filters for adjacent criteria such as modalities, indications, and claim status. Combining this service area view with those filters makes it easier to narrow quickly from discovery to outreach while keeping the process transparent and reproducible.
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Matching companies
- 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. With over 30 years of background in regulatory trends, therapeutic experience, and operational expertise, the company partners with biopharma to advance…
- 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.
- BioAgilytix
Bioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually.
- BioDuro-Sundia
Integrated CRDMO with 30 years of expertise spanning discovery chemistry, biology, DMPK, and IND-enabling development for small and large molecules, plus API and drug product manufacturing.
- Broughton
Global CRO specializing in analytical testing, regulatory consultancy, and compliance support for pharmaceutical, tobacco, and cannabinoid products across FDA, EMA, and other regulatory pathways.
- Caidya
Caidya is a global, full-service CRO delivering personalized clinical development solutions across all phases of clinical research. The company specializes in early-phase development, Phase II/III studies, and clinical operations with deep expertise in oncology & hematology,…
- 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.
- 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.
- Fortrea
Fortrea is a global Contract Research Organization (CRO) with over 30 years of clinical development expertise. The company delivers comprehensive Phase I through Phase IV study management, clinical pharmacology services, and market access solutions to biopharma, biotech, and…
- 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
ICON is a CRO with 8,000 biotech-dedicated professionals offering end-to-end clinical development, consulting, and therapeutic expertise across all development phases.
- ICON plc
Global CRO offering full-service and flexible outsourcing across early clinical, bioanalytical, cardiac safety, specialty laboratory, and clinical operations; serves pharma, biotech, and medical device sponsors from molecule to commercialization.
- IQVIA Real-World Solutions
IQVIA Real-World Solutions leverages 64+ petabytes of proprietary data and 1.2B+ non-identified patient records to accelerate clinical trial site identification and enable evidence-based solutions across 100+ countries.
- Labcorp
Labcorp Early Development Services is part of Labcorp, a global life sciences and healthcare company offering integrated drug development and diagnostic services. The organization supports nonclinical research, central laboratory services, early phase development, regulatory…
- 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.
- Medpace
Medpace is a full-service contract research organization (CRO) dedicated to accelerating the development of safe and effective medical therapeutics. The company operates under a therapeutically-focused, integrated model that provides sponsors with early and ongoing insight…
- 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. The organization provides comprehensive drug development, laboratory, and lifecycle services to pharmaceutical, biotechnology, medical device,…
- 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. The organization delivers Phase I–IV…
- 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.
- 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.
- 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.
- 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
Syneos Health is a comprehensive contract research organization (CRO) offering integrated clinical development and commercialization solutions for biopharmaceutical companies. ## Clinical Development Services The organization provides full-service clinical development…
- 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.
- Velocity Clinical Research
Integrated clinical research site organization operating 60+ sites across the U.S. and Europe, supporting trials that contributed to 61 FDA-approved products since 1986.
- WuXi AppTec
Global 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 CRO
ethica 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.
- uBriGene
uBriGene is a global leader in advanced therapy medicinal products (ATMPs), cell and gene therapy CDMO services, and analytical testing. Headquartered in Maryland with operations across North America and Asia, the company specializes in bridging ATMP concepts from early…
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