LMG provide FDA registration service to Food, Drug, Medical Device and Cosmetic Companies. FDA registration is a mandatory requirement for Food, Drug, and Medical device establishments. FDA registration for cosmetic establishments and products are voluntary. For foreign establishments, our FDA registration services includes FDA agent service also, which is a requisite to complete the registration.
FDA Registration Service for Food Facility
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 successfully 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 which includes a free certificate of FDA registration.
Medical Device FDA Registration Service
Foreign and Domestic medical device establishments marketing their medical devices in the USA are required to register the establishment with FDA and pay the FDA registration fees for each fiscal year. FDA Fiscal year is 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 need to register with the FDA before start marketing in the USA. Unlike food or medical device, Drug establishment registration is not just an online registration; it requires to submit 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 is USD 649/year and drug listing fees are USD 399/Drug.
FDA Registration requirements for Cosmetics
Even though FDA registration is not an obligation to cosmetic establishments, most cosmetic manufacturers insist on FDA registration to prove their commitment to quality and reliability. LMG provide FDA VCRP (Voluntary Cosmetic Registration Program) registration service at a reasonable price to our customers.