The FDA requires foreign manufacturers to appoint a qualified U.S. Agent. We provide that support so your U.S. market entry is more straightforward and organized.
We serve as your FDA U.S. Agent and act as your main point of contact with the FDA. This helps you stay reachable, compliant, and ready for inspections or documentation requests. With a reliable U.S. Agent appointed, you can expect:
Our team guides you through these requirements clearly and efficiently so you can enter the U.S. market with a well-prepared approach.
We provide a valid U.S.-based contact for your FDA records, as required for foreign manufacturers entering the U.S. market.
We help collect, review, and manage the documents required for regulatory correspondence, including product details, labeling, and safety data.
We act as your official point of contact when registering your food facility, medical device establishment, OTC manufacturer, or cosmetic facility with the FDA.
We receive, document, and respond to FDA inquiries on your behalf, ensuring timely, accurate, and compliant communication.
We support you during FDA inspections, notification requests, and documentation reviews to help you avoid delays or compliance risks.
We maintain, update, and renew your FDA registrations each year so your operations remain uninterrupted.
We advise on additional compliance needs such as labeling rules, claims, import requirements, and product pathway considerations.
*Optional services available upon request.
Yes. The FDA requires any foreign manufacturer of food, cosmetics, OTC drugs, dietary supplements or medical devices to appoint an FDA U.S. Agent. This ensures the FDA has a reliable point of contact inside the United States for inspections, questions and regulatory notices.
A U.S. Agent receives FDA communication on your behalf, supports registration updates, helps coordinate inspections and provides a U.S. contact for all regulatory matters. Their role is to make sure nothing is missed and all FDA requests are handled correctly and on time.
Yes. While we can serve as your U.S. Agent, we can also support labeling reviews, ingredient checks, claims assessments and guidance on next steps before entering the U.S. market.
Sometimes they can, although this may create competing priorities. Many companies prefer an independent regulatory partner who focuses only on compliance and communication with the FDA.
Most setups can be completed within one to two business days once we receive the required company information.
