390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA Team
OUR CONSULTANTS

Companies in the United States and 100 countries, recommend ITB HOLDINGS LLC.

You could too.

We take the stress out of your busy day!

WHAT TO EXPECT
  • Multilingual Professionals
  • Multinational Agents
  • They work extended hours so you do not have to
  • Email responses are provided within 30 minutes when we receive relevant information
  • Chat with us, seven days a week
  • You will enjoy our offers
We Deliver Results

With the following services, and much more:

FOOD FACILITY REGISTRATION

SUPPLEMENT FACILITY REGISTRATION

FOOD CANNING ESTABLISHMENT REGISTRATION

PRIOR NOTICE

FOREIGN SUPPLIER VERIFICATION

LABEL REVIEW & DESIGN

Contact Us

    Shortages are leaving doctors, nurses and other frontline workers ill-equipped to care for COVID-19 patients, due to limited access to supplies such as gloves, medical masks, respirators, goggles, face shields, gowns, and aprons.

    Manufacturers, exporters and distributors are invited to contact us, because FDA Registration is required.

    Contact Us

      Some products are both cosmetics and drugs:
      ■ Anti-dandruff shampoos
      ■ Antiperspirant-deodorants
      ■ Moisturizers and makeup with SPF (sun protection factor)

      Therefore, Drug Establishment Registration is required.

      Contact Us

        Annual renewal of registration must occur before December 31 of each year.

        The FDA wants to speed up generic drug or OTC (Over-the-Counter) approval process by offering 8-month and 10-month reviews of abbreviated new drug applications (ANDAs).

        Contact Us

          Labeling for approved OTC drugs and OTC drugs under the monograph system is called Drug Facts. Drug Facts includes information about the purpose and use of the drug, warnings, directions for use, and other information.

           

          Contact Us

            Prior Notice must be provided for all food for humans and animals that is imported or offered for import into the United States.

            Contact ITB HOLDINGS LLC before your next shipment to avoid FDA and CBP detention.

             

            Contact Us

              Contact Us