Research & Clinical Development Solutions

Regulatory Services

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

Multimedia May 26, 2023
Webinar on Advancing Patient Engagement in the Medical Device / MedTech Industry
Engaging with patients, including their caregivers and advocates, is crucial during the planning and execution of clinical trials.
Medical Devices MedTech Patient Engagement
Publications May 25, 2023
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
EU Pharma Regulatory
Blog May 17, 2023
Introduction to Patient Engagement in MedTech in the U.S.
Check out these key takeaways from our Playbook for Patient Engagement in MedTech in the U.S. and access the playbook download.
MedTech Patient Engagement USA
Events May 16, 2023
PSI 2023 Conference
We're excited to talk orphan drugs and rare diseases at the World Orphan Drug Congress in Washington, D.C.
Orphan Drug Pharma Rare Disease UK
Events May 15, 2023
World Orphan Drug Congress USA
We're excited to talk orphan drugs and rare diseases at the World Orphan Drug Congress in Washington, D.C.
Orphan Drug Pharma Rare Disease
Events May 15, 2023
BIO International Convention
We are excited to share that we will be attending the BIO International Convention in Boston. This leading industry event attracts biotechnology and pharma leaders for one week of intensive(...)
Biotech Pharma
Events April 26, 2023
MedTech Forum 2023
We are excited to share that we will be sponsoring and speaking at MedTech Forum 2023. The MedTech Forum is the largest health and medical technology industry conference in Europe and(...)
MedTech Real-World Evidence (RWE)
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