The understanding and evaluation of the regulatory environment for every new product is a complex and intimidating process. Our regulatory consulting staff, many of whom serve on FDA, EPA, OECD and WHO advisory panels and hail from previous senior-level positions within industry or government, can play a key role on any project and provide you with support during both preclinical and clinical development, manufacturing, product licensing and regulatory approvals. Areas of expertise include pharmaceuticals, biologics, medical device, veterinary medicines and agrochemicals.
- Development and registration strategies
- Data review, gap analysis and strategic advice
- Documentation and presentation coaching
- Expert report preparation
- Clinical trial applications and trial support services
- Product license variations and defense
- Product life cycle management
- Participate on scientific and regulatory advisory boards
- Provide scientific and regulatory training on the preclinical aspects of drug development
For more information about our regulatory consulting services, please contact us at 1.877.CRIVER.1 or firstname.lastname@example.org.