We are a highly respected US FDA Agent specializing in assisting manufacturers and exporters worldwide in food, drugs, medical devices, nutraceuticals, and cosmetics. For FDA Facility Registration/Establishment Registration, foreign manufacturers and exporters of food, drugs, and medical devices must appoint an FDA Agent.
The FDA Agent serves as the main point of contact between the facility and the FDA, handling emergency situations and routine registration matters.
US FDA Agent is required for various industries that wish to export to the USA, including drug manufacturers, medical device manufacturers and exporters, food manufacturers and re-packers, nutraceutical manufacturers, API manufacturers, cosmetic manufacturers, testing laboratories and sterilization facilities, among others.
The responsibilities of a US FDA Agent include staying updated with the latest information from the FDA, facilitating facility registration and account maintenance, communicating with the FDA as needed, providing label review services and GMP guidance (additional fees may apply), assisting the FDA with scheduling foreign facility inspections, conducting annual registration updates, updating importer information for drugs and medical devices, allowing additional listings throughout the service year, performing initial Registration and listing, verifying DUNS numbers and addresses, requesting FEI numbers, safeguarding login information, and issuing Registration Certificates.
Foreign manufacturers and exporters should carefully consider the agent’s credentials when selecting a US FDA Registration Agent. Important points to remember to include ensuring that the agent is a lawfully registered firm in the USA, possesses the necessary experience and knowledge in drugs, food, medical device, and cosmetics regulation, is not an individual operating from a personal residence or workplace, is a dedicated full-time company for regulatory compliance, is aware of FDA regulatory updates and communicates them to customers, and maintains neutrality without any affiliation with US importers or dealers.
The US Agent is an independent entity not approved or recognized by FDA authorities. The FDA does not authorize the FDA Agent Certificate.
While FDA food registration is biannual, the FDA Agent agreement is typically made for one year, and customers have the option to choose multiple years and pay annual fees for the agent’s services.