Fees for FDA registration vary based on the industry. We can provide guidance on these fees and helping clients understand how to proceed to ensure all necessary fees are paid and compliance is maintained.
Since February 11, 2002, all international institutions whose goods are manufactured or sold for importation into the United States (human medicines, animal drugs, biological products, and devices) must be licensed with the FDA and classified as United States agents (i.e.: “U.S. agents”). The U.S. agent performs the role of the international facility’s domestic delegate from which all contact with the FDA takes place.
Fees associated with domestic and international clients may differ in regard to the FDA. If you are unsure which FDA registration applies to your company please contact us for more information if you work in industries such as medical devices, food, cosmetics, or drugs.