U.S. FDA Drug Services
Each year between October 1 and December 31, the U.S. FDA requires manufacturers, repackagers, relabelers, and others to register. Registered firms must also list and/or certify the accuracy of the products they are marketing in or importing into the United States.
IUVO Consulting helps companies register their establishments and maintain their drug product listings with FDA. We also help to facilitate the payment of FDA's annual OTC Monograph User Fees (OMUFA), and we assist with GDUFA-required reporting.
The U.S. FDA monitors the entry of regulated products into the U.S. Those that do not meet FDA's regulatory requirements are held until the violations, as identified by FDA in a Notice of Action, have been resolved.
IUVO Consulting helps companies achieve the release of detained products by helping them understand the violations observed by FDA, and by negotiating and facilitating the completion of corrective actions, whenever possible.
Companies that are not based in the U.S. are required to designate a U.S. Agent, who is responsible for communicating directly with FDA on the company's behalf.
IUVO Consulting, LLC provides an affordable, annual U.S. Agent service, which assists companies as defined by FDA. We help to ensure that our clients are able to communicate with FDA quickly and clearly.
When it comes to labeling drug products, the U.S. FDA has requirements regarding what can and cannot appear on the labels. Information such as warnings, active ingredient requirements and instructions are often clearly outlined in the agency's drug monographs.
IUVO Consulting is able to review your labels to ensure that they meet FDA's requirements. We review each relevant section to alert you to information that may need to be added or removed. We can also assist with the design or re-design of your product's labels.