Establishment Registration

Every drug manufacturer, repacker, relabeler, and distributor that intends to market products in the United States must maintain a valid FDA Establishment Registration. Our team provides end-to-end establishment registration services to help you stay compliant with FDA requirements and avoid costly delays.

What We Do
• New FDA Establishment Registration – Guiding you through first-time registration for domestic and foreign facilities.
• Annual Renewal (Oct 1 – Dec 31) – Ensuring your establishment registration is renewed on time each year.
• US Agent Services for Foreign Firms – Serving as your official FDA US Agent to manage communications with the agency.
• Drug Listing Support – Linking product NDC numbers to your establishment registration for full compliance.
• Regulatory Consulting – Ongoing support to maintain FDA compliance and respond to agency queries.

Why Work With Us
✔ Trusted regulatory experts with experience across pharmaceuticals, biologics, and APIs
✔ Fast and affordable registration services with transparent pricing
✔ Complete FDA compliance support – from establishment registration to drug listing and eCTD publishing
✔ Tailored solutions for manufacturers, importers, distributors, and CROs