Research & Clinical Development Solutions

Regulatory Services for Pharma and MedTech

Why choose Alira Health for regulatory support?

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.

Regulatory Services that humanize 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.

Regulatory News

News February 7, 2023
The 2023 MedTech Contract Manufacturing Report is released in the U.S.
Alira Health, a global healthcare advisory, clinical research and technology company, announced today the release of the 2023 U.S. MedTech Contract Manufacturing Report in collaboration(...)
MedTech
Publications February 7, 2023
The 2023 U.S. Medtech Contract Manufacturing Report
Read this report to discover the trends in the world of medical device CDMOs and their meaning for the industry.
MedTech
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
News January 31, 2023
The Playbook for Patient Engagement in MedTech in the U.S. is Launched
The MedTech Patient Engagement Think Tank announced today the launch of the Playbook for Patient Engagement in MedTech in the U.S.
MedTech Patient Engagement
Publications January 31, 2023
A Playbook for Patient Engagement in MedTech in the U.S.
“A Playbook for Patient Engagement in MedTech in the U.S.” is a result of amalgamating ideas, research, findings, and forecasts from industry subject matter experts that together(...)
MedTech Patient Engagement
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
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