U.S. Agent for Global Life Sciences Companies
The United States Food and Drug Administration (FDA) requires pharmaceutical and medical device companies without a presence in the United States to appoint a U.S. Agent. Having considerable experience navigating FDA regulations, members of the Synchrogenix Regulatory Services team are available to serve as the U.S. Agent for global life sciences companies doing business in the United States.
What is a U.S. Agent?
A U.S. Agent serves as an official point of contact between FDA and a foreign company. The U.S. Agent is authorized to send and receive documents and information on behalf of the client with FDA via phone, fax, and email, and to represent the client in meetings with FDA. This service includes access to and use of the COMMUNICATE module of our Regulatory Information Management (RIM) solution.
What functions do U.S. Agents perform?
As U.S. Agent, some of the functions we perform include:
- Coordinate and aid with your correspondence and communication with FDA.
- Assist FDA in communications with foreign establishments.
- Respond to questions concerning a foreign establishment's products that are imported or offered for import into the U.S.
- Assist in scheduling inspections of foreign establishments.
- Provide regulatory consulting and advice to the client, as requested.
- Provide access to expert advice from Synchrogenix subject matter experts in clinical; nonclinical; chemistry, manufacturing, and controls (CMC); and other specialty areas, as needed.
- Access and use of Synchrogenix's GlobalSubmit COMMUNICATE software