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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240

Your Regulatory Consultants


Just image having your own FDA Compliance Department for the fraction of the cost! No salary or bonus to pay.

What to Expect from
our Consultants


  • French
  • Spanish
  • German
  • Dutch
  • Other languages


▪ Multinational

▪ Work extended hours so you do not have to

  • Available for Live Support chat, 24 hours a day and 7 days a week
  • Respond to emails within 30 minutes

We, as consultants, assist companies in Canada, Mexico, Brazil, Australia, New Zealand, India, Pakistan, South Korea, Japan, China, Russia, Portugal, Greece, Spain, Italy, France, Belgium, Netherlands, Switzerland, Sweden, United Kingdom, Ireland, among more than 100 countries.


Most FDA Consultants are highly skilled professionals, whose expertise is provided as part of a contract for a fee or rate.

Our Consultants

  • focus on FDA-regulated products including medical devices, food and beverages, dietary supplements, drugs, and cosmetics.
  • offer services such as FDA registration, product listings, submissions, U.S. Agent services, and more.
Clear Filters
Medical Devices
OTC Cosmetics
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Make sure to provide the following, when you contact us:

▪ Company name.

▪ Complete physical address.

Company DUNS Number.

▪ Products details.

We do understand that running a business can be stressful. So, pass on some of that.

Have someone else, like our FDA Consultants, handle all the FDA Compliance paperwork, while you concentrate on advertising and selling your products our services. Deal?


ITB HOLDINGS LLC, the actual U.S. Agent instead of the individual FDA Consultants, works closely with the U.S. Food and Drug Administration, the U.S. Customs and Border Protection, as well as the National Institute of Occupational Safety and Health (NIOSH), and all U.S. Customs Brokers including FedEx, UPS, DHL.


Foreign establishments or facilities exporting products to the United States, must identify a U.S. Agent such as ITB HOLDINGS LLC, during the FDA registration process for:

  • Food Facility.
  • Food Canning Establishment (FCE).
  • Cosmetic Establishment.
  • Drug Establishment.
  • Medical Device Establishment.

The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Registration Number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.

Just you know, we speak French, Spanish, German, Dutch, Italian and many other languages for your convenience.