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.

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Food

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Medical Devices

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Cosmetics

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Drugs

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Registration Services

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

The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom. The seized products are worth approximately $1.3 million.

Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements.

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

Medical Devices (PPEs)

OTC Drugs (Hand Sanitizers)