U.S. FDA Agent for Foreign Companies


Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of devices, drugs, food, and cosmetics imported into the United States must identify a United States agent (U.S. agent) for that establishment. The U.S. agent acts to communicate between the FDA and foreign companies. For more information about the annual U.S. agent fee per year please contact us.

About Us

U.S. FDA Agent for Foreign Companies

Proregulations offers reliable and low-cost U.S. FDA agent services for foreign companies. It is important to make the appointment of a U.S. Agent since it is a mandatory requirement for foreign companies who wish to import their drugs, medical devices, food and cosmetics into the U.S.

The Responsibilities of a U.S. FDA Agent

  • Assisting FDA in communication with your company.
  • Responding to questions concerning your imported products into the U.S.
  • Assisting FDA in scheduling inspections of your company.
  • If FDA cannot reach out to your company directly, FDA may provide information to the U.S. Agent.

Who Should Consider Appointing a U.S. Agent?

  • Foreign medical device, food and drug facilities intended to register with FDA.
  • Foreign applicants of the IND, NDA, and ANDA.

Why Should You Consider Choosing Our Company as Your U.S. FDA Local Agent?

✓ Professional

We provide U.S. FDA Agent services to our clients around the world and we have an experienced team dedicated to providing professional services to our customers with regulation consulting.

✓ Confidential

It is worth noting that the U.S. authorized agent is not an agent in sales, but an agent in regulatory matters. Therefore, our company always performs our duties in a compliant manner and keeps critical information about your company fully confidential.

✓ Timely

The agent mainly plays a role in communicating and liaison, which will represent you directly to communicate with the FDA. Our company can respond quickly and effectively to any questions or queries of FDA, and ensure smooth communication between FDA and you.

Our company is always committed to providing professional, cost-effective and reliable agency services to effectively protect all the legitimate interests of your company. If you need help or have a question, please feel free to contact us for more details.

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