US FDA Agent Services for Foreign Companies

FDAbasics offers low cost and reliable US FDA Agent Services for foreign companies.

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 the United States.

Responsibilities of US Agent

The US 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 FDA agent plays a significant role in FDA regulatory matters, which can have a direct impact on your business.

We offer 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.

Who should appoint US Agent?

Foreign Food, drug, and medical device facilities intended to register with the FDA.

Foreign applicants of the NDA, NDA, or IND

Foreign Companies intended to submit the controlled correspondence to the FDA

Why Choose our US FDA Agent Services?

Established experienced

Lowest fees

No hidden charges

All services under one roof

Food facility registration and Medical Device registration and listing are both free with our U.S. Agent services

No fees for listing additional devices or proprietary names.

All services under one roof

Strict client confidentiality

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 U.S. Agent requirements helps to answer your questions.

FDAbasics offers a reliable and cost-effective solution for U.S. Agent services for small companies. Please refer to Google and Trustpilot ratings on the home page.

We’re ready to work with you! To appoint us as your US FDA Agent, 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. US Agent fees for drug companies involved in the filing of NDA, ANDA, NADA, and ANADA are based on the volume of regulatory submissions; please contact us.