US Agent Service

We specialize in assisting foreign facilities in Medical Device Establishments, Drug Establishments, and Cosmetic Establishments registered with FDA.

We can act as the US Agent for foreign drug, medical device and supplement facility registrations. As your US Agent, we will respond to FDA questions and help you during meetings with FDA officials.

Why US Agent Service Is Required

Any foreign facility involved in manufacturing, preparing, propagating, compounding, or processing medicines, medical devices, or dietary supplement products imported into the US must appoint a US Agent as its official correspondent. Legally, the US Agent must have a residence in the US and be physically present. Responsibilities of the US Agent include:

  • Helping the FDA communicate with the foreign company
  • Being available in an emergency for the FDA
  • Serving on behalf of the foreign facility to interact with the FDA 
  • Responding to questions concerning the foreign establishment’s drug, device or supplement products

In case of being unable to contact the foreign company expeditiously or directly, the FDA provides documents or information to the US Agent. Such action is considered equivalent to providing the same information or documents to a foreign establishment.

Our Responsibilities as the US Agent

Over the years, we have successfully represented many foreign establishments as their US Agent Service provider. We specialize in assisting foreign Dietary Supplements Facilities, Food and Beverage Facilities, Medical Device Establishments, and Drug Establishments registered with FDA.  Besides fulfilling all the responsibilities listed above, we also serve as a reliable liaison between clients and the FDA. We will help you:

  • Re-inspect your establishment
  • Handle your product detained at a US port
  • Ensure proper communications with the FDA
  • Schedule and negotiate FDA inspections
  • Address compliance questions that may come your way
US Agent

Frequently Asked Questions

Any foreign facility involved in manufacturing, preparing, propagating, compounding, or processing medicines, medical devices, or food and beverage products imported into the US must appoint a US Agent as its official correspondent. The US agent is responsible for:

  • Helping FDA communicate with the foreign company
  • Being available in an emergency as the FDA contacts no other personnel
  • Serving on behalf of the foreign facility to interact with the FDA 
  • Responding to questions concerning the foreign establishment’s products

In case of being unable to contact the foreign company expeditiously or directly, the FDA provides documents or information to the US Agent. Such action is considered equivalent to providing the same information or documents to a foreign establishment.

Over the years, we have successfully represented many foreign establishments as their US Agent Service provider. We specialize in assisting foreign Dietary Supplements Facilities, Food, and Beverage Facilities, Medical Device facilities, and Cosmetic facilities registered with the FDA.  Besides fulfilling all the responsibilities, we also serve as a reliable liaison between clients and the FDA. We will help you:

  • Re-inspect your establishment
  • Handle your product detained at a US port
  • Ensure proper communications with the FDA
  • Schedule and negotiate FDA inspections

Address compliance questions that may come your way

Yes, the US Agent must have a residence in the US and be physically present.

Want US Agent Service for Your Foreign Facility?

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