Your Target Product Profile Can Be the Key to Regulatory Success

Target Product Profile solution. Graphic of pills in the shape of the globe.

Regulatory strategy hinges on having the end in mind from the outset

“Begin with the end in mind” has become a popular catchphrase, but only because it proves itself to be true time and time again. You can more easily comply with regulatory requirements by expending increased effort into your target product profile. This is the foundation of your regulatory strategy and sets the stage for future development considerations. It is the second of ten elements of regulatory strategy:

  1. Summary of guidelines/precedents from multiple agencies
  2. Target product profile
  3. Agency interaction plan and timeline
  4. Identification of regulatory data requirements
  5. Assessment of registration routes and mechanisms globally
  6. Consideration of country registration timelines to meet business objectives
  7. Early market access and reimbursement plan
  8. Consideration of external influencing
  9. Lifecycle support and supplemental application plan
  10. Risk management and post-marketing plans

Continue reading

A Well-Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

A Well Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

The level of investment required and inherent risks in development of today’s new and advanced biopharmaceutical products are greater than ever posed in the history of the industry.  Pharmaceutical products are more specialized, technology is more complex, the regulatory environment more tortuous, global markets for these products are more competitive and return on investment may be uncertain at the early stages of product development.  Additionally, new clinical development tools and regulatory principles, e.g., enrichment strategies, adaptive trial designs, breakthrough designation, are emerging that enable more efficient clinical development, as well as, more expedited approval pathways for new therapeutic approaches to disease management. Continue reading