U.S and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. All facilities located outside of the United States must also designate a U.S. Agent for FDA communications. Both companies Manufacture and Importer if different must be registered. FDA requires the DUNS number for every register Establishment. We will provide you with a UREG certificate for the confirmation.
One business day
Yearly between October 1 and December 31
Add to cart & pay service fees
Fill out the form on the website after checkout
Get your form reviewed by our experts.
Receive your certificate for registration