Regulatory: Pharma

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

Related news

M&A MedTech Pharma
News January 13, 2022
Alira Health Secures an Additional $40M in Funding, Led by Creadev
We announced today the closing of an equity financing in which it raised gross proceeds of US$40 million. We intend to use the funds to invest in solutions that actively engage patients(...)
Pharma
Events December 23, 2021
Event: Presentation of the 2021 BioRegion Report
We are thrilled to announce that Alira Health has contributed to the BioRegion Report 2021,
Clinical Pharma
Publications December 21, 2021
An Insider Look at Vaccines: Yesterday, Today, Tomorrow
The COVID-19 pandemic has put vaccines in the spotlight. The pandemic has given the industry a considerable boost, and with lessons learned during the development and roll-out(...)
Advanced Analytics Digital Health Pharma Research & Development
Publications December 10, 2021
Leveraging Data Intelligence for Effective Opportunity Screening and Prioritization in Drug Discovery
Our biotech client needed an innovative, effective way to identify which binding sites and therapeutic indications they should target for the development of new therapeutic agents for(...)
Pharma
Events November 21, 2021
Webinar: RWE in Pharma: An Expert Panel Discussion
Join Catia Proenca, PhD, for a webinar on RWE in Pharma.
Clinical Digital Health MedTech Pharma
News November 16, 2021
Alira Health Further Expands its Digital Healthcare Platform with the Acquisition of Patchai
We acquired Patchai, a digital health technology company headquartered in Italy. Patchai offers intelligent digital health solutions that engage and empower patients in clinical research(...)
Pharma
Events November 1, 2021
Event: World Orphan Drug Congress Europe 2021
Join us at the World Orphan Drug Congress on November 15-18.
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.