fda registration services

Domestic and foreign companies that are involved in the production and distribution of medical devices or drug products intended for use in the United States, are required to register annually with the U.S. Food and Drug Administration (U.S. FDA). This process is known as establishment registration.

Join thousands of satisfied clients in more than 100 countries. Reach millions more customers willing and able to buy your products.

ITB HOLDINGS LLC assists companies around the world with their FDA Registrations, including manufacturers of N95 masks, ventilators and other COVID-19 (Coronavirus) personal protective equipment (PPE), as well as hand sanitizers covered by the Emergency Use Authorization (EUA) .

Are you exporting or importing other products, instead? We can help, too.

Registration Services

For Domestic and Foreign Companies


■ Establishment registrations are based on FDA’s fiscal year which runs from October 1 to September 30.
■ Domestic and foreign companies are required to have a DUNS (Data Universal Numbering System) Number issued by Dun & Bradstreet Inc to all types of business organizations including sole proprietorships, corporations, partnerships, non-profits, and government entities.

    Sophie Glen

    Senior FDA Consultant

    I enjoy helping with FDA Registrations.

    Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
    Food Facilities
    Medical Devices (PPEs)
    OTC Drugs (Hand Sanitizers)