Are you a non-US manufacturer of Pharmaceutical Products & Medical Devices, or Foods & Food Products? Let Wellkang LLC be your reliable US Agent registered with the FDA - U.S. Food and Drug Administration!
US Congress authorized FDA to collect an annual establishment registration fee for device establishment registrations submitted to the FDA after September 30th, 2007, please learn more here.
Our Services & Fees for Foods & Food Products:
Since December 12, 2003, ALL food facilities (both domestic and foreign) MUST be registered with the FDA. Any foreign facilities not registered will have their goods held at the U.S. port of entry or moved to an FDA secure location. All foreign food facilities must include the name of a “US Agent” with their registration. The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.
Our Services & Fees for Cosmetic Products:
The program consists of two parts: The registration of cosmetic manufacturing establishments and the filing of cosmetic product ingredient statements with the FDA.
Our Wellkang team, a world leading regulatory consultancy, are ready to help you!
For more information, please visit our Questions and Answers section.
Sell to US? Here are your solutions: www.FDA-Registration.com www.FDAagent.us www.510k.org
Sell to Europa? Here are your solutions: www.CE-marking.com www.Auth-Rep.com
Sell to China? Here are your solutions: www.CCC-mark.com www.CCC-mark.cn
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