Special Designation Assessment & Support

In the dynamic realm of medical innovation, attaining special designations from the U.S. Food and Drug Administration (FDA) represents a significant milestone for life sciences companies. These designations are specifically crafted to facilitate and expedite the development and review of drugs targeting unmet medical needs in severe or life-threatening conditions. They hold utmost importance for companies on the brink of breakthroughs, especially those with promising clinical data, poised at a development turning point, or recently infused with funding to expand operations.

FDA special designations—such as Fast Track, Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Rare Pediatric Disease—can profoundly influence the product development trajectory. They offer advantages like enhanced FDA guidance, more frequent agency interactions, and eligibility for expedited review processes. These benefits are invaluable for organizations navigating the intricate regulatory landscape efficiently and expediting therapies to market to benefit patients in dire need.

Our method for securing FDA special designations is thorough and personalized. We commence by:

• Strategic Evaluation: Assessing your product's potential to meet special designation criteria and reviewing precedent for similar products in the same indication.
• Comprehensive Planning: Identifying the optimal timing to request a designation based on essential data availability and development milestones.
• Application Preparation and Submission: Crafting a compelling evidence package that showcases your product's data and scientific merits.