Regulatory Strategy CROs in United States

A leading global contract research organization acquired by Thermo Fisher Scientific. PPD provides comprehensive clinical development services including laboratory, data management, and regulatory services.

Global biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities. Syneos offers end-to-end solutions from Phase I through product launch and beyond.

Leading IRB, IACUC, and consulting services provider for clinical and preclinical research, plus site management and performance optimization services.

US-based CRO providing full-service Phase I-IV clinical trial support for small and mid-size pharma and biotech with expertise in CNS, oncology, and infectious disease.

Full-service CRO purpose-built for small and mid-size biotech, combining legacy of CATO Research, SMS Oncology, Pharm-Olam, and Nuventra into an integrated clinical development partner.

Full-service CRO integrating translational sciences, clinical pharmacology, bioanalysis, and regulatory strategy from preclinical through Phase IV development.

Full-service CRO based near FDA headquarters with 25+ years of regulatory and clinical trial expertise including adaptive designs, BE/BA studies, and pharmacovigilance.

Phase I-III oncology CRO providing clinical trial management with deep oncology expertise for small and mid-size pharma and biotech sponsors.

Miami-based full-service CRO specialising in complex and rare disease clinical trials with deep regulatory expertise for accelerated and breakthrough therapy designations.

Clinical research organization providing Phase I-III clinical trial management, monitoring, and regulatory services with a focus on small-to-mid-size biotech and specialty pharma sponsors.

Regulatory affairs and clinical development consultancy providing full-service FDA/EMA submission support, pharmacovigilance, and clinical trial management for small pharma and biotech.

Full-service mid-size CRO specialising in rare diseases, transplantation, nephrology, and immunology across Phase I-IV trials.

Full-service, technology-enabled oncology-focused CRO serving biotechnology and pharmaceutical companies across all clinical phases from Wilmington, Delaware.

Biosimulation and regulatory science company providing model-informed drug development, regulatory science consulting, and software solutions for the pharmaceutical industry.

Global full-service CRO founded in 1995 with strong Asia-Pacific and European presence, expanded via acquisition of CROMSOURCE for deeper European clinical operations.

The only global full-service CRO focused exclusively on CNS drug development, with involvement in 22 FDA-approved CNS therapies across 13 indications.

Technology-enabled mid-size clinical CRO offering Phase I-IV development services with particular strength in oncology, rare disease, and CNS therapeutic areas.

Mid-size US CRO providing full-service Phase I-IV clinical trial management with expertise in oncology, rare disease, and CNS across 50+ countries.

Pennsylvania-based dermatology and aesthetics specialty CRO providing Phase I-IV clinical trial management and site services for topical, injectable, and device-based products.

New Jersey-based mid-size CRO and FSP provider offering clinical operations, data management, and regulatory services across 40+ countries.

Specialty CRO focused exclusively on CNS clinical trials, neurocognitive endpoint assessments, and central rater training for Phase I-III neuropsychiatric studies.

US-based clinical-stage CRO arm specialising in endocrinology and cortisol-modulation therapeutics with expertise in Phase I-III metabolic and CNS clinical trials.

US-based CRO specializing in rare disease and pediatric clinical trials, providing end-to-end trial management with deep expertise in orphan drug development and regulatory strategy.

Biostatistics-focused CRO and software company pioneering adaptive trial design, group sequential methods, and clinical trial simulation for pharma and biotech.

Global tech-enabled full-service CRO with strength in government-sponsored trials, infectious disease, vaccines, ophthalmology, and rare disease clinical development.

Global real-world evidence and outcomes research firm providing observational studies, health economics, market access, and regulatory evidence generation for pharma and biotech.

Contract research organization spun off from Labcorp in 2023. Provides Phase 1–4 clinical development services, patient access solutions, and regulatory consulting globally.

Life science regulatory and clinical development consultancy specialising in regulatory strategy, quality management, and organisational support for biotech and pharma.

Global clinical research and health data analytics company formed from the merger of IMS Health and Quintiles. Offers end-to-end clinical development, real-world evidence, and technology solutions.

Retina-specialty CRO with offices across Latin America, Asia, and Australia supporting clinical trials in 18+ countries for ophthalmic and rare disease indications.

US-Korea bridge CRO providing early-phase clinical and regulatory services tailored for Korean life science companies entering the US FDA pathway.

Cincinnati-based full-service CRO providing Phase I-IV clinical trial management, clinical pharmacology, and regulatory consulting services for pharmaceutical and biotech sponsors worldwide.

Oncology CRO founded by oncology thought-leaders specializing in Phase I and II immuno-oncology trials in North America and Europe.

Scientifically-driven, global, full-service clinical CRO providing Phase I-IV clinical development services. Medpace is known for its therapeutic expertise and operational efficiency.

Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.

US-India hybrid CRO providing clinical trial management, regulatory affairs, pharmacovigilance, and medical writing with cost-effective offshore delivery from India.

Mid-size CRO acquired by IQVIA providing boutique-level clinical development services with deep therapeutic expertise in oncology, CNS, and rare disease for small-to-mid-size biotech sponsors.

Clinical pharmacology consulting firm specializing in PK/PD modeling, dose optimization, biosimilar development strategy, and regulatory science for pharmaceutical and biotech companies.

Regulatory consulting firm providing IND/NDA/BLA submission strategy, CMC consulting, and FDA interaction management for biotech and pharmaceutical sponsors.

World's leading ophthalmology-specialized CRO providing full-service clinical development from Phase I through Phase IV exclusively for ophthalmic therapeutics, devices, and surgical products.

Cambridge-based specialty CRO focused on biostatistics, statistical programming, clinical data management, and regulatory submission support for pharma and biotech.

Regulatory affairs and medical writing CRO providing IND/NDA/BLA preparation, regulatory strategy, and clinical documentation support for pharmaceutical and biotech companies.

Clinical data management and biometrics CRO specializing in biostatistics, statistical programming, and data management for small to mid-size pharmaceutical and biotech companies.

Mid-size full-service global CRO offering Phase I-IV clinical trial management with strong coverage across emerging markets in Africa, Latin America, and Eastern Europe.

Specialty CRO focused on oncology and rare disease with 2,000+ professionals, known for biomarker-driven trial design, companion diagnostics, and translational research services.

Full-service global CRO providing clinical development services across all phases with deep expertise in CNS, rare disease, and cardiovascular therapeutic areas and strong site networks.

Global regulatory consulting, pharmacovigilance, and clinical research organization providing single-source regulatory strategy, compliance, and medical information services.

California-based clinical CRO providing Phase I-III trial management, monitoring, and project oversight for emerging biotech and small pharma sponsors.

MedTech CRO formed by the 2020 merger of Regulatory and Quality Solutions and Maetrics, delivering 40+ years of medical device regulatory, clinical, laboratory, and reimbursement expertise.

Full-service CRO founded on biostatistics and data science excellence, supporting Phase I-IV trials across rare disease, immunology, and ophthalmology from Research Triangle Park.

Full-service contract research and consulting organization providing clinical trial management, biostatistics, data management, and regulatory services with particular expertise in rare disease and pediatrics.

Full-service CRO providing clinical research, biostatistics, data management, and regulatory services with particular expertise in ophthalmology, CNS, and rare disease.

Specialty CRO with 20+ years of dermatology, aesthetics, gastroenterology, and inflammation clinical trial expertise across the US, Europe, and Australia.

Integrated biopharmaceutical solutions company combining clinical development and commercial capabilities to accelerate customer success from Phase I through product launch.

Consulting arm of Syneos Health providing commercial and regulatory advisory, launch planning, and market access strategy for pharmaceutical and biotech clients.

California-based mid-size CRO providing full-service Phase I-III clinical trial management with deep expertise in oncology, rare disease, and CNS for emerging biotech.

Mid-size CRO specializing in clinical development for small and emerging biotech companies. Now part of Allucent, offering Phase 1–3 trial management and regulatory consulting.

Mission-driven global CRO (formerly FHI Clinical) with 50+ years of heritage managing complex clinical research in resource-limited settings across Africa, Asia, Latin America, and North America.

Oncology-focused CRO founded on the Mayo Clinic campus offering preclinical-to-clinical oncology development with PDX models, flow cytometry, and Phase I/II trial management.

Innovation CRO purpose-built for medical device and IVD development, delivering integrated regulatory, clinical, and laboratory services across cardiovascular, neurological, and ophthalmic indications.

Specialized biometrics and regulatory CRO providing biostatistics, data management, medical writing, and regulatory strategy for pharmaceutical and biotech companies seeking FDA and EMA approvals.

Leading provider of clinical trial solutions including IRB/ethics review, site performance optimization, data analytics, and clinical trial management services for the pharmaceutical industry.