Bridge innovation with speed and efficiency. Position your program for differentiated success.
The Challenge
505(b)(2) programs offer an accelerated, cost-effective path to approval, but companies often struggle to navigate the hybrid regulatory requirements. Challenges include identifying the right reference product, designing bridging studies, building a credible FDA strategy, and framing a value story that appeals to partners or investors.
JRC’s Solution
- Strategic assessment of 505(b)(2) opportunity and reference product selection
- FDA engagement strategy and regulatory pathway mapping
- Design and coordination of bridging studies (clinical pharmacology, bioequivalence, etc.)
- Labeling strategy, CMC bridging and comparative data planning
- Positioning for licensing, partnership, or investor discussion
Results We Deliver
- Defined efficient development plans that reduce clinical burden and costs
- Successfully guided FDA interactions for complex hybrid submissions
- Created investor-ready stories around repurposed or reformulated assets
Developing a 505(b)(2) asset with strategic potential?
Let’s build a plan that bridges regulatory logic and commercial value.