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 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.

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Publications June 23, 2022
Developing Data Specialist Talent: Collaboration Is Key
Companies across Pharma and MedTech need talented people to cover the range of data-related challenges. Discover what this means for developing talent throughout the industry.
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Increasing Access to Genomic Testing in Europe
Listen to the episode “Increasing Access to Genomic Testing in Europe: The role of national genomic initiatives in increasing uptake of Advanced Diagnostics”.
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The Impact of Chip Shortage on the MedTech Sector and RAS Players
Discover the three factors driving the chip shortage, the impact, and what’s next for Robotic and MedTech industry at large.
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Events May 19, 2022
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
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We acquired RedCrow, an alternative investment platform that provides individual investors with easy access to expert-vetted healthcare start-ups. The financial terms of the transaction(...)
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U.S. and European Regulatory Strategies for Asian MedTech Startups
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
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