DSI Regulatory Affairs consultants have extensive experience interacting with FDA reviewers within CBER and CDER.
We understand individual reviewer’s “must haves” in terms of data or development studies, and work with you to develop communication strategies that carefully consider how applications from prior sponsors may shape a Division’s perspective for your product.
Our approach to FDA interaction is and has always been an open, consistent and meaningful dialog that allows your company adequate time to respond to any concerns.
Our Regulatory Affairs Consultants:
- Ensure that you are prepared to communicate your development plans at agency meetings
- Identify potential issues and develop strategies to answer Chemistry, Manufacturing and Controls (CMC) questions
DSI keeps you and the FDA on “the same page” at critical and time-of-approval commitments, smoothing the way to keep your program on track.
- Pre-IND and End of Phase 2 question development
- Briefing documents
- Agency Meetings — Attendance, Interactions, Discussion, Conclusion, Commitments