The U.S. Food and Drug Administration (FDA) requires food and beverage, cosmetic, medical device, drug, and radiation-emitting device companies located outside of the United States to designate a U.S. Agent when registering with FDA for FDA communication.
FDA requires your U.S. Agent to have a permanent address in the United States. As your U.S. Agent, our service extends beyond just communicating with FDA on your behalf. You will also receive:
Assurance that your facility’s unique facility identifier (UFI), unique device identifier (UDI), or facility establishment number (FEI) is accurate
Updates to your FDA Registration
Assistance with Prior Notice filings for your exports to the USA
Detention Assistance when seeking the release of a detained shipment
Access to Automated Compliance for Exporters, an innovative supply chain management platform
Note: A DUNS number is the only UFI currently recognized by FDA for food facility registration.
clients
countries
years of service
10,000+
180+
5+
FDAConsulting brings over 5 years of experience and expertise to regulatory compliance.
Contact us now!
FDAConsulting
Fill out the form and we will contact you shortly to discuss how you can launch a product in the US market.