Smith Associates can act as the U.S. Agent for any non-U.S. medical company. The duties of a U.S. Agent, as defined by the Food and Drug Administration are:
Assisting FDA in communications with the foreign establishment.
Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment.
Registering and updating establishment and product information.
Maintaining an office address in the United States.
EXPANDED SERVICE:
In addition to the basic service, Smith Associates also offers a more comprehensive U.S. Agent package, which includes these additional services:
Handling U.S. Custom queries; and
5 hours of additional regulatory consulting services.
Smith Associates accepts Visa, MasterCard, American Express and Discover credit cards