NDA/BLA Support CROs in United States

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

Global CDMO with 30+ years delivering development and manufacturing for biologics, cell therapies, viral vectors, and mRNA across US, European, and Asian facilities.

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.

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

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

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

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

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

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

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

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

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.

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.

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

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.

US-based biomanufacturing CDMO founded in 2020 delivering end-to-end development and manufacturing for biologics, mRNA, and cell and gene therapy across a domestic facility network.

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.

Global CDMO with integrated small molecule, biologics, and gene therapy manufacturing including proprietary viral vector platforms across the US, Europe, and Asia.

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

Fully integrated dermatology-dedicated CRO providing nonclinical through Phase III development services exclusively for skin disease products since 1997.

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.