US Agent, official correspondent, registration, listing:

Very few establishment types are exempt from registration, listing and paying FDA fees. But for all other types, we act as a buffer between you and FDA, and we would represent you based on yearly flat fee. You will never receive additional invoices based on “incidents”. This includes establishment registration, device listing, US agent and official correspondent.

To find your establishment type and the FDA requirements that apply please visit this page: Who Must Register, List and Pay the Fee

Certificate to Foreign Government:

 We assist establishments with US presence that we already represent, in order to obtain CFG (Certificate to Foreign Government) from US FDA.

FDA inspection:

FDA’s inspection policies and procedures are detailed at this link. We assist you during the inspection in order to minimize 483 deficiencies, as well as after FDA’s inspection in order to avoid a Warning letter.