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Fees: Registration for U.S. Drug Establishments
U.S. Drug Establishments that are not exempt from FDA's registration and listing requirements must designate a Registrant Contact for FDA communications. Registrar Corp serves as the Registrant Contact for many U.S. firms. As your Registrant Contact, Registrar Corp's team of Drug Regulatory Specialists provides guidance as to required elements, formats and particularities of submissions for US$ 995 annually 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.
