What it is
FDA requires every non-US facility to designate a US Agent — an official point of contact inside the United States. We serve as your US Agent for a flat annual fee.
Who needs it
Any facility outside the US that is registered, or needs to register, with FDA.
What's included
- Official US Agent designation for your facility
- Receipt and fast relay of all FDA communications
- Coordination of responses with your team
- Continuous support to keep your registration valid
How it works
- 1
Sign up and designate Soluma as your US Agent.
- 2
We appear on your registration as your official US contact.
- 3
We handle FDA communications and alert you immediately when action is needed.
Frequently asked questions
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