LMG provides FDA registration services to Food, Drug, Medical devices, and Cosmetic Companies. FDA registration is a mandatory requirement for Food, Drug, and Medical device establishments. FDA registration for cosmetic establishments and products is voluntary. Our FDA registration services include FDA agent service for foreign establishments, which is a requisite to complete the registration.
If you have a food manufacturing, processing, packing, or holding facility and the food products from your facility is marketing in the USA, you need to register your food facility with FDA. If your facility is outside the USA, you must have a US FDA Agent to complete the registration. Domestic facilities do not require a US Agent to complete the registration.
After successfully completing the registration, FDA will assign an eleven-digit registration number to each facility. This eleven-digit FDA registration number is a prerequisite for issuing the prior notice.
If you need assistance with FDA food facility registration or US FDA Agent service, please complete our online Food Facility Registration Form. Our fees for FDA Registration and US Agent service are USD 349/year, including a free certificate of FDA registration.
Medical Device FDA Registration Service
Foreign and Domestic medical device establishments marketing their medical devices in the USA must register the establishment with the FDA and pay the FDA registration fees for each fiscal year. FDA’s Fiscal year is from October 1st to September 30th.
LMG’s FDA registration service includes FDA fee payment assistance as well. LMG fees for Medical device establishment registration and US FDA Agent service is USD 449/year. Please complete our online Medical Device Establishment Registration Form to start the registration process.
Drug Establishment Registration and Listing Service
Establishments that manufacture or process drugs that include prescription, OTC, and homeopathic drugs must register with the FDA before starting marketing in the USA. Unlike food or medical device, Drug establishment registration is not just an online registration; it requires submitting the registration in SPL format to FDA. Foreign drug establishments must have a US Agent to complete the FDA registration.
If you are looking for an expert to prepare and submit the FDA registration and listing SPL, please submit our online Drug Establishment Registration Form. LMG fees for FDA Registration for drug establishment are USD 649/year, and drug listing fees are USD 399/Drug.
FDA Registration requirements for Cosmetics
As per the new Modernization of Cosmetics Regulation Act of 2022 (MoCRA); Cosmetic establishments engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register with FDA.
LMG provides FDA registration service at a reasonable price to our customers.