Services to Ease FDA Regulatory Compliance

FAQ: US Agent

What are the responsibilities of a US Agent?

US Agents have a number of responsibilities. These include: Acting as an intermediary for communications between the FDA and foreign companies. Provides assistance to answer any questions concerning the foreign establishment’s devices that are imported or offered for import into the United States Assists the FDA to schedule inspections of the foreign establishments  Acts as a … Continue reading What are the responsibilities of a US Agent?

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. … Continue reading How much is the US Agent fee?

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.

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 … Continue reading How much time will it take to appoint a US Agent?

FDA US Agent

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