Case Study

Successful Submission of a Complex NDA for a Breakthrough Therapy- Designated Product

A biotech sponsor with whom we have a long-standing relationship asked our regulatory and biostatistical experts to lead the NDA submission efforts for their breakthrough therapy designated product. When delays in the program’s phase 3 program database locks occurred, we leaned upon our regulatory expertise and clinical trial acumen to meet the target NDA timeline.

Successful NDA submissions require a foundational regulatory and clinical strategy that can adapt to the challenges and competing priorities of the drug development process and ultimately drive the program forward. Download our case study to learn more about the approaches and activities we implemented to meet timeline goals, including:

  • Consistent, Multi-disciplinary “Core Team” Approach
  • Program Risk Analysis
  • Ability to Leverage Efficiencies and Experience
  • Team Focus on the Important Key Benefit: Risk Messages
  • A Collaborative and Trusting Relationship