FDA US Agent Services
Any foreign company that wished to sell food or beverage products, medical devices, cosmetics or drugs in the U.S. must do so via an authorized U.S. Agent.
U.S. Agent For FDA Registration
U.S. agents may be a private company or an individual that resides in the U.S. and, as such, is subject to U.S. legislation. Foreign businesses must provide details about their U.S. Agent to the FDA, including their registered address and telephone number. The U.S. Agent acts as an intermediary between the FDA and the foreign establishment. The FDA contacts the U.S. Agent directly in the case of any updates relating to registration to approval.
Communication with the FDA
Communicate directly with the FDA on your behalf
Quickly and efficiently respond to any questions or queries arising from either the FDA or the foreign establishment, in relation to applications or approvals.
Coordinate between the FDA and the foreign establishment to organize inspections.
Ensure a smooth flow of communication between the FDA and all of our foreign clients
What is a U.S. Agent?
In the U.S., Agents act as an intermediary between the FDA and foreign companies. A U.S. Agent can be either an individual or a company, and they do not hold registrations for the foreign company, as is common outside of the U.S.
Do I need a U.S. Agent?
All foreign companies who which to market products that are either regulated or approved by the FDA must do so via a U.S. Agent. FDA Agents are usually the first point-of-contact for the FDA. They then relay information about submissions, holds or approvals to the foreign manufacturer.
We offer other Services for the United States
In the U.S. the FDA regulates all food and beverage products that are intended for human or animal consumption.
U.S. FDA regulates all cosmetic products that are intended to be sold and used in the US.
Manufacturers of Dietary Supplements must ensure that their products are safe and accurately labelled