Move fast. File smart. Capture market before the competition.
The Challenge
For generic companies aiming to be first to file under Paragraph IV, speed and precision are everything. But identifying the right target, coordinating bioequivalence studies, preparing for patent certification, and managing U.S. FDA submission timelines requires a level of regulatory and operational expertise many teams lack internally.
JRC’s Solution
- Early target identification and PIV risk-benefit analysis
- BE study design, CRO matching, and project oversight
- U.S. regulatory pathway consulting and FDA eCTD submission support
- Paragraph IV certification strategy and legal coordination planning
- Market entry scenario planning (launch strategy, pricing, GPO access)
Results We Deliver
- Accelerated ANDA filings with strong dossier quality
- Improved BE success rates through CRO and PI optimization
- Early positioning with U.S. distributors and formulary committees
Planning to lead the market with a first generic?
We help you compete with speed and confidence.