Regulatory Strategy CROs
Global regulatory strategy development including pathway selection and submission planning.
9 organizations offer this service
ICON plc
FeaturedGlobal 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.
Syneos Health
FeaturedIntegrated biopharmaceutical solutions company combining clinical development and commercial capabilities. Syneos offers end-to-end solutions from Phase I through product launch and beyond.
PPD (Thermo Fisher Scientific)
FeaturedA leading global contract research organization acquired by Thermo Fisher Scientific. PPD provides comprehensive clinical development services including laboratory, data management, and regulatory services.
Parexel International
FeaturedGlobal biopharmaceutical services company providing clinical research, regulatory consulting, and market access services. Parexel has supported the development of many blockbuster drugs.
Medpace
Scientifically-driven, global, full-service clinical CRO providing Phase I-IV clinical development services. Medpace is known for its therapeutic expertise and operational efficiency.
NAMSA
Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.
Novotech
Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.
Certara
Biosimulation and regulatory science company providing model-informed drug development, regulatory science consulting, and software solutions for the pharmaceutical industry.
Intertek Pharmaceutical Services
Global testing and certification provider offering comprehensive pharmaceutical services including analytical testing, stability studies, extractables/leachables, and regulatory consulting.