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.
Pragmatic Compliance LLC offers US Agent services for drug companies at highly competitive fees. With twenty years of experience, we have strong expertise in handling a wide range of regulatory communications with the FDA on behalf of foreign companies. Our have fast turnaround times, meaning we avoid delays in regulatory approval that could cause problems for your product launch. And we have experience in all types of regulatory communications – controlled correspondence, deficiency response, DMFs, ANDA,IND, NDA, NADA and ANADA – that will benefit your business.
Our US Agent fees for foreign companies depend on the nature of your business and the number of regulatory submissions required. Please contact us for more information. You can find our more in our FAQ section on the requirements, roles and responsibilities of a US FDA Agent.
We offer guaranteed lowest prices without compromising the quality of our services. We offer additional discounts to small companies and free of charge services for non-profit organizations. Get in touch today to find out more.