Nuventra has considerable experience with regulatory agencies around the globe. We work with our clients and the regulatory agencies to ensure that all documents are robust, insightful, scientifically focused and practical. You have invested significant resources to reach this point, contact the experts at Nuventra to ensure your submissions and/or strategic responses are well received by the agencies.
Regulatory, Writing & Strategy
- Gap Analysis/QBR
- Guidance Document Interpretation
- NDA/BLA (Full or Sections)
- NDA/BLA Publishing and Submission (CTD/eCTD)
- Regulatory Agency RFIs, Meetings, Meeting Requests, Planning, Briefing Packet Preparation, Representation