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! A world leading consultancy offers you excellent services at very competitive prices!
About Medical Devices & Pharmaceutical Products:
Since February 11, 2002,
- ALL Foreign Establishments whose products (Human Drugs,
Animal Drugs, Biological Products, and Devices) are
imported or offered for import into the United States MUST be REGISTERED with the FDA, and
- designated a United States Agent, i.e. a "US Agent".
- The US Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.
About 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.
Wellkang LLC is a member company of the Wellkang Group of Companies- a world leading consultancy group in FDA affairs incl. 510(k) PMN submission, UL, CCC Mark, CE Marking. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in Asia, Europe and America.
For more information, please visit our Questions and Answers section.