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

Explore our related publications.

Events February 21, 2024
XXII Conferenza Nazionale Sulla Farmaceutica
Meet Giovanni Firenze, Partner Consulting Italy, onsite in Catania and learn more about the impact of the new AIFA reform.
Italy Regulatory
Events September 28, 2023
Regulatory Roundup
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
MedTech Regulatory
Publications September 22, 2023
Impact of the New EU HTA Regulation on Access to Innovative Medicines in Europe
In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.
Biotech Healthcare Technology Regulatory Spain
Publications August 1, 2023
The EU Pharmaceutical Package: Impact on Orphan Medicinal Products
This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).
EU Pharma Regulatory
Publications July 10, 2023
The EU Pharmaceutical Package: Regulatory Protection Changes
Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).
EU Pharma Regulatory
Publications June 14, 2023
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.
Medical Devices Regulatory
Publications May 25, 2023
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
EU Pharma Regulatory
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.