Alira Health

Alira Health

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.

News June 18, 2024
Alira Health Partners with Scottsdale Research Institute for Psilocybin Clinical Trials Funded by the State of Arizona
Alira Health, a global advisory and clinical research firm, announced today its collaboration with the Scottsdale Research Institute (SRI) to provide comprehensive regulatory and clinical(...)
Clinical Trials Regulatory
Case Studies May 8, 2024
Mid-Size Medtech Company with a Borderline Product Defines Strategy for EU Launch
Medtech company sought support in developing a regulatory strategy for the EU launch of their product with an aggressive timeline to launch.
Medical Devices MedTech Regulatory
Events April 30, 2024
The MedTech Forum 2024
We are thrilled to announce that we will exhibit and speak at The MedTech Forum 2024.
MedTech Regulatory
Articles April 17, 2024
The Challenges for Medtech in a Complex Regulatory Landscape in 2024
Learn more about what manufacturers in the US and Europe should consider when developing their regulatory strategies and prioritizing their target markets from regulatory affairs expert Mercè Guerra.
Medical Devices MedTech Regulatory
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
Reports 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
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