CRO Finder

Regulatory Strategy CROs

Global regulatory strategy development including pathway selection and submission planning.

9 organizations offer this service

ICON plc

Featured
Dublin, Ireland Full Service

Global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. ICON specializes in clinical research with operations across 53 countries.

GCP Compliant ISO 9001 ISO 27001

Syneos Health

Featured
Morrisville, NC, USA Full Service

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

GCP Compliant ISO 9001

PPD (Thermo Fisher Scientific)

Featured
Wilmington, NC, USA Full Service

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

GLP GCP Compliant CLIA CAP

Parexel International

Featured
Durham, NC, USA Full Service

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

GCP Compliant ISO 9001

Medpace

Cincinnati, OH, USA Full Service

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

GCP Compliant CLIA CAP

NAMSA

Northwood, OH, USA Testing Lab

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

GLP ISO 17025 ISO 13485 FDA Registered

Novotech

Sydney, Australia Specialty

Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.

GCP Compliant ISO 9001

Certara

Princeton, NJ, USA Specialty

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

ISO 9001

Intertek Pharmaceutical Services

London, UK Testing Lab

Global testing and certification provider offering comprehensive pharmaceutical services including analytical testing, stability studies, extractables/leachables, and regulatory consulting.

GLP GMP ISO 17025 FDA Registered