Mind the Gap: The Importance of Gap Analysis in Securing Regulatory Approval
Significant pressure to achieve regulatory approval to start generating return on investment can affect any sponsor, but it is of the greatest importance to small biopharma companies without existing marketed products. Biopharma companies may have conducted successful research and put in the work to warrant approval and market access, but to an uninitiated sponsor bridging the gap between good science and regulatory expectations is not always intuitive.
We partnered with Informa Pharma Intelligence to help you understand how to move drugs more successfully through the regulatory approval process.
In this whitepaper, discover the importance of:
- Conducting a thorough gap analysis to prepare for an NDA or BLA
- Implementing FDA advice
- Developing an analytical control strategy and development data comparability
- Creating nonclinical summaries to preserve institutional memory
- Having complete oversight of your applications and where they are in the process