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
To learn more about Charles River's extensive consulting services portfolio, visit the Charles River Consulting Services section.
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Regulatory consulting, regulatory consultants, drug development, FDA, EPA, OECD, WHO, preclinical drug development, clinical trial applications, drug manufacturing, product licensing, regulatory approvals, pharmaceuticals, pharmaceutical drug development, biologics, medical device
Regulatory Consulting | Drug Development | Charles River Navigator Services
Charles River Navigator Services is a global network of scientific and regulatory consultants and program managers who can offer you more solutions to navigate the drug development process.