Regulatory Affairs and Communication
- Regulatory consulting and advising (US and ex-US)
- Communication liaison between global Health Authorities (e.g., U.S. FDA, Health Canada, EMEA) and Sponsor
- Pre-IND/IND/NDA (FDA PDUFA) meeting support
- Meeting preparation (e.g., meeting requests, briefing documents, rehearsals)
- Attendance with Sponsor at formal meetings
- Evaluation of need for (and value of) FDA pre-IND consultation
- Preparation for and Sponsor representation at FDA Advisory Committee meetings
- Gap analysis/needs Assessment
- Determination of preparedness