Home » Our Services » Regulatory » Health Authority Interactions

Health Authority Interactions

Assistance for Interactions with FDA/EMA/National Health Authorities

We offer comprehensive regulatory services to facilitate FDA and EMA interactions, including communication and strategic guidance for our clients. From preparing and submitting meeting requests to representing sponsors at FDA meetings, analyzing responses, and offering regulatory advice, we’re dedicated to navigating complex pathways with expertise. We assist in EMA and EU National Health Authorities interactions, attending pre-submission meetings, providing scientific advice, and engaging with Innovation Offices, all aimed at optimizing regulatory outcomes for our clients.

How We Help Clients

FDA Interactions

As part of our regulatory services, the Alira Health team can:

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

EMA and EU National Health Authorities Interactions

As part of our regulatory services, the Alira Health team can prepare and attend:

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

Why Choose Us for Your Health Authority Interactions?

Expert Guidance: Rely on our experienced team for strategic counsel and expert representation during interactions with FDA, EMA, and EU National Health Authorities, ensuring informed decisions and favorable outcomes.
Comprehensive Support: Benefit from our end-to-end assistance, from preparing meeting requests and packages to attending meetings, analyzing responses, and providing regulatory advice tailored to your specific needs.
Proven Success: Trust in our track record of successful interactions with health authorities, backed by our commitment to excellence and dedication to achieving regulatory milestones for our clients.