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.

Strategies

In the setting of today’s competitive environment and limited funding opportunities, a focused regulatory drug-development plan is critical. THinc partners with pharmaceutical clients to create streamlined and integrated clinical, nonclinical, and CMC drug-development strategies that optimize the timing of and expenditures on studies intended to support successful product registration. Our expertise includes

  • Analyses of client objectives, development programs, and product data to develop strategic approaches for
    • Pre-IND Meetings
    • End-of-Phase 2 Meetings
    • Pre-NDA Meetings
    • Advisory Committee Meetings
  • Interpretation of current regulations and regulatory guidelines, policy statements, and trends that impact overall drug-development strategies
  • Gap analyses of development programs
  • Regulatory due diligence for in-licensing or funding assessments
THinc