The Situation
- A well-established European pharmaceutical company was establishing a U.S. subsidiary to develop and launch several drug products in the U.S. The pharmaceutical company faced challenges as they lacked internal expertise with US FDA requirements and were relying on outdated advice from a previous Regulatory consultant.
The Solution
- EVERSANA’s Regulatory Consulting provided full regulatory support for the U.S. market, including interpreting and providing guidance for PDUFA goal timing and fees, providing regulatory strategy, assistance with authoring of meeting requests and meeting packages pertaining to non-clinical, clinical, and CMC content, NDA content authoring, labeling design and content support, proprietary name requests, publishing and submission of all FDA correspondence and submissions, performing expert reviews, authoring deficiency responses, FDA Prior Approval Inspection (PAI) support, driving/supporting launch readiness activities, including but not limited to, FDA drug listings, Advertising & Promotional (Ad/Promo) material reviews and approvals, and support for state licensing required for drug product distribution.
- EVERSANA’s Regulatory Consulting also assigned a consultant who stepped in as their Head of Regulatory for the U.S. subsidiary and was the FDA liaison for all communication. The regulatory expert managed the preparation of and aided with authoring of all five modules for several NDAs.
The Results
- FDA approved NDAs including all amendments that resulted during FDA review cycle
- Final Product Labeling and Structured Product Labeling (SPL)
- Successful FDA drug listings
- FDA compliant advertising and promotional materials