Home › Fees › Drugs › Registration and U.S. Agent Requirements for Non-U.S. Drug Establishments
Fees: Registration and U.S. Agent Requirements for Non-U.S. Drug Establishments
Non-U.S. Drug Establishments that are not exempt from FDA's registration and listing requirements must designate a U.S. Agent and Registrant Contact for FDA communications. The U.S. Agent's responsibilities under this regulation are typically different from those of an agent used for business purposes. Having Registrar Corp as your U.S. Agent prevents conflicts of interest that may arise when importers or brokers serve as U.S. Agents. The fee for Registrar Corp to serve as your U.S. Agent and Registrant Contact is US$ 995 annually. As your U.S. Agent and Registrant Contact, Registrar Corp's team of Drug Regulatory Specialists provides guidance as to required elements, formats and particularities of submissions including:
Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with FDA and make changes, updates and cancellations as needed.
Your drug label is a required element of your drug listing. If your Drug Label does not meet FDA requirements, Registrar Corp can provide labeling assistance for an additional fixed fee of US$ 1,495. Once compliant, Registrar Corp will prepare and submit your drug label to FDA on your behalf.
Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
