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
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