The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or pharmaceuticals, medical devices, food and dietary supplements, in United States.
The agent acts to communicate between the FDA and the company. All FDA communications on important regulatory information – such as compliance issues, product related problems or inspection schedules – will come through the agent, so you should make sure that your chosen agent has a clear understanding of all regulatory compliance matters. Your agent plays a major role in FDA regulatory matters, which can have a direct impact on your business.
Pragmatic Compliance LLC offers US FDA Agent services to clients around the world, building on over twenty years of experience. We provide a cost-effective, high quality service, with basic prices starting from just $299 for food, dietary supplement, drug and medical device companies. There are no hidden costs and we do not increase our fees for annual subscriptions.
Your choice of US FDA Agent could mean the difference between a successful and unsuccessful process, so take the time to think through your needs. You may find our FAQ section on US Agent requirements helps to answer your questions.
We’re ready to work with you! To appoint Pragmatic as your US FDA Agent, simply fill in the online form and complete the payment process. Once we’ve received your payment, we’ll start supporting your registration and regulatory communications. U.S Agent fees for drug companies involved in filing of NDA, ANDA, NADA and ANADA are based on the volume of regulatory submissions. Please contact us for more information.