ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-389-7344
+1 855-510-2240
info@m.itbhdg.com

FDA
COMPLIANCE
MADE EASY

EXPAND YOUR MARKET
Global FDA Registration and Compliance Services

Canadian, Mexican, Brazilian, European and Asian regulations are not similar or equivalent. Why would you take a chance?

Whereas the United States has always relied on a strictly centralized process through one agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 27 member countries of the European Union, while preserving national “autonomy.”

The biotech industry asserts that the U.S. drugs and or devices approval is much slower than in Europe, and that European patients enjoy earlier access to innovative drugs and technology over U.S. patients. Furthermore, product liability lawsuits are less common in Europe than in the United States. That explains why initial approval of U.S. company-backed devices is increasingly being sought in the E.U. before any application is submitted to the FDA in the United States.

However, CE Marking is not FDA Approval or Clearance. Facility or Establishment Registration and product listing are require to expand your market.

Food

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Medical Devices

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Cosmetics

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Drugs

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For Domestic and Foreign Companies

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Unique Facility Identifier (UFI)
■ Domestic and foreign companies must 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.
■ Now required for all FDA Registrations: Food Facility, Food Canning Establishment, Drug Establishment, Medical Device Establishment.

    FDA NEWS

    U.S. FDA’s laboratory testing found that some honey-based products samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction.

    Περισσότερες από 1336 ελληνικές εταιρείες τροφίμων είναι εγγεγραμμένες στον FDA των Ηνωμένων Πολιτειών.

    Más de 4873 empresas alimentarias españolas están registradas ante la FDA de Estados Unidos.

    4473개 이상의 한국 식품 회사가 미국 FDA에 등록되어 있습니다.

    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings.
    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 REGISTRATIONS TRENDS
    Food Facilities
    0%
    Medical Devices (PPEs)
    0%
    OTC Drugs (Hand Sanitizers)
    0%