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
- Market access
Explore our related publications.
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White Paper: New European Health Technology Assessment Regulation
In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.
How to leverage registry-based studies to generate high-quality Real-World Evidence
The use of Real-World Evidence (RWE) in regulatory decision making will support the development and application of better medicines.
How to successfully use the EMA IRIS portal to ensure timely submissions
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Webinar Replay: What You Should Know About MDR Best Practices, Including PMCF
Discover the major changes introduced by the MDR, including the post-market requirements, and especially the Post-Market Clinical Follow-up (PMCF).
DTx France 2022
We are pleased to announce that we will be joining as speakers and exhibitors at DTx France 2022. This hybrid event will focus on the latest DTx trends, regulatory framework, market(...)
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.