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FDA COMPLIANCE MADE EASY

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.

Registration Services

For Domestic and Foreign Companies

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

    CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson (Janssen) vaccine.

    As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S.

    All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

    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.
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    Medical Devices (PPEs)
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    OTC Drugs (Hand Sanitizers)
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