US FDA AGENT AND FDA REGISTRATION 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 US FDA Agent. Also, companies will require an FDA registration agent.

US FDA AGENT

US FDA agent 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 US FDA agent, including their registered address and telephone number. The FDA registration 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

FAST REPLY

Quickly and efficiently respond to any questions or queries arising from either the FDA or the foreign establishment, in relation to applications or approvals.

ORGANIZE INSPECTIONS

Coordinate between the FDA and the foreign establishment to organize inspections.

SMOOTH FLOW

Ensure a smooth flow of communication between the FDA and all of our foreign clients

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