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