FAQ: US Agent
Change of U.S. agent FDA -How it will impact ?
Change of U.S. agent FDA Change of U.S Agent will not affect your registration or business. You can change the U.S Agent name in the FDA registration anytime. How to change US Agent information in the FDA registration? Login to your account Update information in the US Agent section Submit the registration US Agent will … Read More
Responsibilities of US Agent
Below are the Responsibilities of US Agent Acting as an intermediary for communications between the FDA and foreign companies. Provides assistance to answer any questions concerning the foreign establishment is one of the crucial responsibilities of US Agent. Assists the FDA to schedule inspections of the foreign establishments Acts as a representative for the foreign company… Read More
How much is the US Agent fee?
Our standard US Agent fee is $299 for one year. However, if your company has potential regulatory submissions, which might include NDA, IND, ANDA, Controlled Correspondence, or PMA, then fees may be more, as these services require more frequent involvement of the US Agent. For food and dietary supplements companies, US Agent fees are $299... Read More
How much time will it take to appoint a US Agent?
We can complete the US Agent appointment formalities in just 20 minutes, using through our online system. As soon as you provide your company information and make the payment, we can give you US Agent details to include in your regulatory submission or registration. Click here to sign our US Agent contract. If you are a drug… Read More
Do I need a US Agent?
US Agent appointment is mandatory for all foreign companies who wish to market their drug, food or medical device products in the United States. In the vast majority of cases, the FDA communicates with companies through the US Agent.