Any foreign company involved in the processing, manufacturing, packing, testing or the performance of any operation on the drug products or drug substance within the United States must appoint a US Agent. This is a mandatory requirement.

Foreign companies are required to submit details about their Agent during Establishment Registration and GDUFA self identification, and in all the regulatory submissions, including drug master file, ANDA and NDA.

The US Agent plays a crucial role in the regulatory submissions process. All FDA communications are channelled through the agent to the foreign company.