ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States

EXPAND
YOUR MARKET
TODAY

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

FDA REGISTRATION SERVICES

Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.

ITB HOLDINGS LLC assists companies around the world, including manufacturers, exporters, importers, distributors, and warehouses.

■ OUR SERVICES ARE OFFERED 24/7

For the following products requiring FDA RegistrationFoodsDietary Supplements, Alcoholic Beverages, Medical Devices, Medical Apps, Prescription Drugs, Over-the-Counter (OTC) Drugs, Active Pharmaceutical Ingredients (APIs), Cosmetics, Radiation-Emitting Products, Vaccines, Blood & Biologics, Animal & Veterinary Products.

Just in case you feel the need to switch U.S. Agent, we make the process easy. Get the better service your company deserves.

    FDA NEWS

    All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K.


    Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidance can no longer be sold or distributed by manufacturers after March 31, 2022.


    FDA has approved new labeling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used.


    www.m.itbhdg.com
    www.fda.itbhdg.com
    www.itbhdg.com

    Exporting Hand Sanitizers or PPEs?
    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings. Make sure your DUNS Number is current.

    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.
    CURRENT FDA REGISTRATION TRENDS
    Food Facilities
    0%
    Medical Devices
    0%
    OTC Drugs
    0%


    END-OF-THE YEAR
    SPECIALS

    $99.00

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