New OTC/Drug Facility Registration: $750
Annual Renewal OTC/Drug Facility Registration: $500
OTC/Drug Facility De-Registration: $350
Act as US Agent for Foreign Company: $250
Certificate for Drug Listing: $200
Certificate for Establishment Registration: $200
Wholesale Drug Distributors & Third Party Logistics Facility Report: $500
Annual Blanket Certification for Drugs: $750
OTC and Prescription Drugs Label and Ingredient Review: $750
Facility Registration & Device Listing: $750
Facility Registration Renewal: $700
FDA Facility Filing Fee: $5,672
Medical Device Listing for 1st Device: $300
Certificate for Export/Free Sale: $300
Certificate for Establishment Registration: $200
Act as US Agent for Foreign Companies: $250
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.