As part of our regulatory services in pharma, the Alira Health team can:
- Prepare and submit meeting request and packages to FDA for various 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 mock FDA meetings to prepare clients for FDA meetings
