Regulatory: MedTech
FDA Meeting Preparation and Representation
Our services: FDA meetings.
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
Why choose Alira Health?
As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:
- Regulatory strategy
- Regulatory intelligence
- Regulatory operations
- Clinical
- Market access