Regulatory: MedTech

FDA U.S. Agent for Non-U.S. Companies

Providing guidance and expertise as liaisons

As a global company headquartered in the U.S., we understand the challenges of working with FDA regulatory as a non-U.S. organization. Our team of U.S.-based project managers have years of experience working with the FDA, and regularly guide our clients through the process as an FDA liaison.

Our liaisons serve in active negotiation with regulatory bodies, providing expertise and guidance for our clients on:
  • FDA establishment registration and device listing
  • FDA U.S. agent for foreign establishments
  • EU authorized representative

Why choose Alira Health?

With Alira Health as your partner, you will benefit from:

  • Innovation support, optimizing product development success every step of the way
  • Integrated and collaborative teams experience
  • Lifecycle approach

Related news

M&A MedTech Pharma
News January 13, 2022
Alira Health Secures an Additional $40M in Funding, Led by Creadev
We announced today the closing of an equity financing in which it raised gross proceeds of US$40 million. We intend to use the funds to invest in solutions that actively engage patients(...)
Clinical Digital Health MedTech Pharma
News November 16, 2021
Alira Health Further Expands its Digital Healthcare Platform with the Acquisition of Patchai
We acquired Patchai, a digital health technology company headquartered in Italy. Patchai offers intelligent digital health solutions that engage and empower patients in clinical research(...)
Clinical Digital Health MedTech Pharma
News October 28, 2021
Alira Health Acquires BEPATIENT, A Step Forward in Humanizing Healthcare
We acquired BEPATIENT, a European healthcare technology company. BEPATIENT offers ‘real life’ digital patient data capture solutions for large pharmaceutical manufacturers, medical(...)
MedTech Pharma
News October 27, 2021
Alira Health Launches Series of Exclusive Barcelona Networking Events
We are launching series of exclusive Barcelona Life Sciences networking events! Join Barcelona Life Sciences community and gain valuable industry insights while meeting like-minded people.
MedTech
Publications September 27, 2021
A Robotic-Assisted Surgery (RAS) Review: Clinical Landscape, Commercial Arena, and Future Outlook
Today’s $7B global Robotics-Assisted Surgery (RAS) market is projected grow to $30B in 2030. Download Alira Health’s Full RAS report to understand adoption dynamics today – technologies,(...)
MedTech
Multimedia August 6, 2021
Alira Health’s Transformation Talks: Overcoming Challenges to Reimbursement in Robotic Surgery for the French Market
Our latest Alira Health Transformation Talks is all about Robotic Surgery.
MedTech
Events August 5, 2021
Event: The MedTech Conference
Join the Alira Health team at AdvaMed September 29-30, 2021 in Minneapolis, MN.
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.