Regulatory Affairs
Labeling and Promotional Materials
Labeling and Promotional Materials services cover all aspects of label and promotional material development, including negotiations with both DDMAC (drugs) and APPLS (biologics) committees. Here are some of the services Pacific BioDevelopment offers in this arena:
- Assist with the development and implementation of systems and procedures for investigational and commercial labels/labeling, promotional, and educational materials review and approval
- Assist with the establishment, implementation, and reporting procedures for NDC Drug Listing systems
- Assist with the development and implementation of launch plans and strategies for advertising, press releases, sales brochures and formulary kits, including vendor selection
- Assist with the development and strategies for pre- and post-approval activities, including conventions and press materials, and FDA pre-clearance strategies
- Perform training for regulatory, marketing, corporate communications, and field sales and establish promotional review systems
- Review website design and content for compliance
- Provide interim management and oversight for clients without internal staff
