IND Filing 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.

GLP-compliant preclinical CRO in Austin, Texas, offering 100+ validated xenograft efficacy models, IND-enabling toxicology, and RNAi therapeutic development services.

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.

Gene therapy and viral vector CDMO in Columbus, Ohio, with 20+ years of leadership and 500+ GMP drug substance batches produced for rare and ultra-rare disease programs.

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.

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

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.

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.

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

Independent not-for-profit preclinical CRO offering full IND-enabling GLP toxicology programs, inhalation toxicology, and immunogenicity testing from the Illinois Institute of Technology campus.

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.

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.

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.

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

Durham-based CDMO using proprietary ARCUS genome editing technology to develop and manufacture next-generation allogeneic cell and gene therapy programs.

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.

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.

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

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.