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.

Regulatory Applications

THinc collaborates with clients to develop the strategies for regulatory submissions, then executes these strategies by preparing, managing, and submitting documentation such as

  • NDAs in CTD format, including supplements
  • IND Applications and Information Amendments
  • Meeting Packages
  • Orphan Drug Designation Requests
  • Fast-Track Designation Requests
  • Breakhrough Therapy Designation Requests
  • Special Protocol Assessment Requests
  • Drug Master Files
  • Safety Reports
  • Development Safety Update Reports
THinc