Having considerable experience navigating FDA regulations, certified members of GlobalSubmit’s Regulatory Services team are available to serve as the US Agent for global life sciences companies doing business in the United States.
GlobalSubmit’s acting U.S. Agent is authorized to serve as an official correspondent of a foreign company, i.e., participate in meetings with FDA regulatorys on their behalf. A U.S. Agent is also authorized to provide documents and information to government regulators.
As listed on the FDA’s official website, a U.S. Agent is able to perform the following functions:
- Assist FDA in communications with a foreign establishment
- Respond to questions concerning the foreign establishment’s products that are imported or offered for import into the U.S.
- Assist in scheduling inspections of the foreign establishment