IRAS Inc offers a US Agent Service to foreign clients looking to enter US markets.

US Agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment’s agent is not physically present [21CFR 207.39a)(11)].

•  Assist the FDA in communications with the foreign drug establishment
•  Respond to questions concerning the foreign drug establishment’s products that are imported into the Unites States
•  Respond to questions concerning applications that have been submitted to the FDA
•  Assist with Drug Establishment Registration (annual re-registration), and Drug Listing