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.
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
U.S. and European Regulatory Strategies for Asian MedTech Startups
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
Cheat Sheet: MDCG Guidance on Medical Device Classification
Assigning the proper class to a medical device (MD) is one of the most important activities carried out by a manufacturer. Read Alira Health's cheat sheet MDCG Guidance on Medical Device(...)
Alira Health Strengthens Clinical Operations with the Acquisition of Sourcia
We acquired a full-service Contract Research Organization (CRO), Sourcia, that provides services for Phase I to Phase IV clinical trials with a focus on biotech, medical devices, and(...)
The FDA’s Project Orbis Can Speed up the Delivery of Your New Oncology Drug to Global Markets
Are you developing an oncology drug? Project Orbis, a program coordinated by the U.S. Food and Drug Administration (FDA), allows you to register your product in several countries with(...)
European Commission’s New Regulation Amending IVDR Transitional Provisions: What You Need to Know
The European Commission (EC) has published an amendment of the IVDR, delaying the transitional period for some IVDs. However, the IVDR Date of Application remains the same, so Alira(...)
Webinar Recap: Risk Management & Regulatory Submissions
Download Alira Health's Senior Vice President, Regulatory Affairs, Mary McNamara-Cullinane's webinar presentation, How to Implement Risk Management into Regulatory Submissions Using(...)