Navigating the pathway to differentiated success
The 505(b)(2) pathway allows for faster-to-market alternatives to new chemical entities.
We specialize in:
Product ideation:
Identifying clinical unmet needs and drug repurposing opportunities.
New delivery systems:
Developing injectable-to-oral switches, faster-acting formulations, and novel drug delivery systems for existing molecules.
Regulatory bridging:
Pharmacokinetic modeling and bio/clinical waiver strategies to minimize the need for extensive clinical trials.