US Agent Services for FDA Compliance

Ensure smooth U.S. market entry and regulatory compliance with Catain Labs, your trusted FDA US Agent. We help foreign manufacturers manage FDA registration, product listings, inspections, and ongoing compliance requirements.

What Are FDA US Agent Services?
A US Agent for FDA is a required point of contact for foreign manufacturers doing business in the United States. Catain Labs acts as your official US Agent, representing your company in all communications with the FDA. Our services ensure timely responses to regulatory inquiries, notifications, and inspection coordination.

Why Foreign Manufacturers Need a US FDA Agent?
Foreign companies manufacturing or distributing drugs, medical devices, food, or dietary supplements in the U.S. must appoint a US Agent. This ensures:
Compliance with FDA registration and product listing requirements
Efficient communication with FDA officials
Coordination during FDA inspections or audits
Access to guidance for ongoing regulatory compliance

Benefits of Appointing Catain as Your US Agent
At Catain, we specialize in acting as a dedicated US Agent for global manufacturers. Our team has extensive experience with:
Pharmaceutical products: DMF, ANDA, NDA support
Medical devices: 510(k), PMA submissions
Food and beverage products: FDA facility registration, FSVP compliance
Dietary supplements: Labeling, regulatory guidance, and compliance

We simplify FDA communication and keep your company fully compliant.

Partnering with Catain Labs as your FDA US Agent provides:
24/7 FDA communication – Always available for urgent inquiries
Regulatory support – Assistance with registration, listing, and documentation
Inspection coordination – Support during FDA inspections and audits
Confidentiality & professionalism – Protecting your sensitive business information
Affordable solutions – Flexible plans for companies of all sizes

Industries We Support 
US Agent Services for Pharmaceutical Manufacturers
We help drug manufacturers navigate FDA requirements, including DMF submissions, ANDAs, and NDAs, ensuring smooth communication and compliance.
US Agent Services for Medical Device Companies
Catain supports device manufacturers with 510(k) submissions, PMA guidance, and FDA inspections to ensure U.S. market readiness.
US Agent Services for Food & Beverage Manufacturers
We assist with FDA Food Facility Registration, labeling compliance, and FSVP requirements, helping your products enter the U.S. market smoothly.
US Agent Services for Dietary Supplement Companies
Our team provides label review, regulatory guidance, and US Agent representation for supplement manufacturers seeking FDA compliance.

How to Appoint Catain as Your FDA US Agent?
Getting started is simple:
Contact Us – Share your company and product details.
Agreement & Authorization – Receive a formal authorization letter for FDA submission.
Registration & Listing – We handle FDA establishment registration and product listing.
Ongoing Support – Continuous management of FDA communications, updates, and inspections.