UNITED STATES AGENT SERVICES FOR FOREIGN MANUFACTURERS
To import their products into the United States for sale or for investigation, foreign Pharmaceutical & Medical Device producers must have a resident U.S. Regulatory Agent.
As your U.S. Regulatory Agent, S&C:
Assists the manufacturer, if required, with registering its establishment and listing its drugs and/or devices with FDA.
Assists FDA with communications with the manufacturer.
Responds to FDA questions regarding the manufacturer’s products.
Assists FDA with the scheduling of inspection visits to the manufacturer’s premises.
Receives documents from FDA on behalf of the manufacturer.
If you would like more information regarding this service, please fill out this form and one of our agents will contact you.
IN THE U.S.: Phone: 888-326-3311 Fax: 972-446-6622 E-mail: Webmaster
IN THE U.K.: Phone: +44 (0) 1243 779550 Fax: +44 (0) 1243 781563 E-mail: bpearce@shotcarr.com
