Responsibilities
of FDA US Agent

The agent acts to communicate between the FDA and the foreign 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.

We 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 $5000.00 for (1)initial medical device companies. There are no hidden costs and we do not increase our fees for annual subscriptions.

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Established device for FDA

About us

previously known as Tobias Systems, started in 1995. The initial focus was on FDA US Agent services to numerous foreign companies for selling medical devices, drugs, and food products in the United States. As our experience built, so did our services, to include DMF filings, ANDA/NDA filings, and Establishment Registration, as well as a range of other services related to FDA compliance. We are now proud to offer expert support that draws on over twenty years of operation.

We are committed to providing the highest quality services for food, medical device, drug, and cosmetics companies. Our focus is on providing you with the advice you need, not just for regulatory consulting but for your long-term business goals. We pride ourselves in offering expert, cost-effective solutions. We have worked with companies large and small, from all around the world

Responsibilities of FDA US Agent

Upcoming Events

Established device for FDA

About us

Responsibilities
of FDA US Agent