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

Publications February 2, 2023
Outlook 2023: Firms Prepare For ‘World Where Health Care Has No Limits’
In the latest publication by Medtech Insights by Pharma Intelligence, executives at top device companies and other stakeholders share their expectations.
MedTech Pharma
Publications January 20, 2023
Insights on Market Access
To get her perspective on market access and what to expect in 2023, we spoke with Nerea Blanqué, Senior Vice President of Market Access and Pricing at Alira Health.
Market Access Medical Devices Pharma
Publications January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Medical Devices MedTech Regulatory
Publications January 18, 2023
The State of Biopharma Funding
We spoke with Joris Pezzini, Executive Vice President of Biopharma, Alira Health, during the J.P. Morgan Healthcare Conference in San Francisco, which brings together investors and(...)
Biopharma Biotech Funding Pharma
Publications January 11, 2023
Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know
Given that the regulation is likely to change considerably, drug developers may need to revisit their development strategy. In the meantime, building a strategy around these evergreen(...)
EU Rare Disease Regulatory
Publications December 21, 2022
2022 Recap: Your Favorite Alira Health Publications
In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)
Clinical Digital Health Market Access MedTech Pharma Regulatory
Multimedia December 17, 2022
Webinar Replay: Partnering with Patients to Streamline Trial Operations: Protocol to Regulatory Submission in 60 days
Learn how patients and patient advocacy organizations can be directly enabled as powerful partners to facilitate all stages of DCT deployment, from protocol design, recruitment, engagement(...)
Clinical Trials Patient Centric Regulatory
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.