Regulatory

Comprehensive Regulatory Services for Pharma and MedTech

Why choose Alira Health?

The Alira Health regulatory team has decades of global regulatory experience and can deliver tailored strategies, efficient submissions, and successful approvals for:

  • Devices
  • Biotech
  • Digital Health
  • Diagnostics

Global expertise in healthcare and life sciences

Regulatory approval moves your product from innovation to market, and the right regulatory strategy requires a complete understanding of the requirements that govern your market.

With our broad knowledge base and expertise, Alira Health provides full-service regulatory affairs, from strategy to submission for both medical devices (MedTech) and pharmaceutical products.

Working together to transform healthcare

Whether you need to understand which asset best aligns with your long-term strategy, which new market or therapeutic area to explore, or how to expand into another sector, we are ready to help you lead the way.

Contact us
Giacomo Basadonna
Giacomo Basadonna, MD, PhD
Chief Medical Officer
With a full range of regulatory affairs experience in both Europe and the U.S., we guide clients to market quickly and in a cost-conscious way.

Related News

MedTech
News July 22, 2021
Alira Health Welcomes Fredrik Nyberg as Partner and Regional Head
We are pleased to announce that Fredrik Nyberg has joined Alira Health as Partner and Regional Head
Due Diligence Pharma
News July 21, 2021
Alira Health Announces its Role as Strategic Advisor to Naxicap
Alira Health is proud to announce its role as strategic advisor to Naxicap in the equity investment in Ceres Pharma Bv.
Regulatory
Events July 20, 2021
Webinar Recap: Risk Management & Regulatory Submissions
Download Alira Health's Senior Vice President, Regulatory Affairs, Mary McNamara-Cullinane's webinar presentation, How to Implement Risk Management into Regulatory Submissions Using(...)
Regulatory
Publications July 20, 2021
Infographic: The Pre-IND to Market Approval Roadmap in the U.S.
Download our latest infographic, The Pre-IND to Market Approval Roadmap in the U.S.
MedTech
Events July 15, 2021
Event: Cardio Wearables 2021 Conference
Join Piergiulio Lauriano for an exclusive discussion on Cardio Wearables Investments and M&A Trends during the conference.
MedTech Pharma
Events June 30, 2021
Event: Bio Asia-Taiwan
Join Daniela Sica, Vice President, Business Development, Pharma & Biotech, and Shu-Ling Cheng, Partner, at Biotechnology Innovation Organization's Bio-Asia Taiwan July 21-25, 2021.
MedTech
Publications June 2, 2021
Infographic: U.S. Go-to- Market Strategy Design for Wearable Technology in Healthcare
When our client, a European healthcare-based startup developing wrist wearables wanted to expand to the U.S., the Alira Health team helped develop a go-to-market strategy for this new segment.

Our locations around the globe

Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.