FDA Compliance for Drug Establishments
Drug products — including prescription and over-the-counter (OTC) drugs — must meet strict FDA requirements before they can be distributed in the United States. From facility registration to drug listings and Master Files, compliance is critical to staying on the market.
USAgentPros helps drug manufacturers, packagers, and distributors meet these requirements with clarity and confidence.
Key FDA Requirements for Drug Facilities
- Establishment Registration – All facilities involved in making or distributing drug products must register with FDA.
- Drug Product Listings – Every drug in U.S. commercial distribution must be listed with FDA.
- Annual Renewal – Registrations and listings must be renewed between October 1 and December 31 each year.
- Drug Master Files (DMFs) – Companies can confidentially submit proprietary information to FDA.
- U.S. Agent Representation – Required for foreign facilities.
Our Drug Compliance Services
- Establishment registration and renewal support
- Drug listing preparation and submission
- DMF (Drug Master File) preparation and eCTD submission
- U.S. Agent representation for foreign companies
- Ongoing compliance monitoring and updates
FDA Requirements are complex, but we make compliance easy.
Navigating drug regulations doesn’t have to be overwhelming. With the right experts on your side, you can ensure accuracy, avoid delays, and stay compliant. Let Registrar Corp handle your FDA compliance needs.
Why Drug Companies Choose USAgentPros
Dedicated Compliance Pro – An expert guiding every submission
Fast Turnarounds – Keep your products on the market without delay
100% Money-Back Guarantee – Confidence built into every service
Competitive Pricing – Professional support at fair rates
Start Your FDA Drug Compliance Process
Stay compliant with FDA drug regulations and keep your products moving into the U.S.