THinc . . . a REGULATORY AFFAIRS DEPARTMENT
For clients who need regulatory affairs support, we can help you strategize, formulate, and develop solutions to regulatory issues and prepare and process submissions that are compliant with regulatory guidelines.
Interactions with Regulatory Agencies
When it is important to seek guidance from regulatory agencies related to the development and review of your investigational products and marketing applications, THinc can
- Advise and prepare clients for regulatory meetings
- Identify potential agency questions/issues and develop strategic regulatory responses
- Role play
- Create presentations
- Conduct formal and informal contacts with regulatory agencies and write meeting minutes. For example, we can
- Prepare 15-day safety reports
- Negotiate and resolve clinical holds
- Lead and facilitate meetings (e.g., EOP2, pre-NDA) with FDA
- Represent clients at meetings with regulatory agencies
