- Prepare and submit meeting requests and packages to FDA for Type A, Type B (Pre-IND and End-of-Phase Meetings) and Type C meetings with the FDA and analyze FDA responses.
- Represent the sponsor at FDA meetings and in other correspondences with the FDA.
- Advise our clients on regulatory options and potential pathways.
- Conduct rehearsal meetings to prepare clients for FDA meetings.
Regulatory: Pharma
Health Authority Interactions (FDA/EMA/National Health Authorities)
- Pre-Submission Meetings with the EMA and Rapporteurs.
- Oral explanation for Orphan Drug Designation, Marketing Authorization Application.
- Scientific advice or Protocol assistance for orphan drugs.
- EU Member States National Health Authorities’ interactions including Scientific advice and interactions with Innovation Offices.
- EMA Innovation Task Force (ITF) Briefing Meeting.
- SME briefing meetings.