390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA Renewals
FDA REGISTRATION RENEWALS

The following domestic and foreign companies must renew their registration before December 31, 2021, regardless of when the initial registration was completed:

  • OTC Drug Establishment
  • Prescription Drug Establishment
  • Medical Devices Establishment

Contact us any time, 24/7, should you have more questions.

We also invite you to consider our offer below, for additional savings.

Please make sure to obtain a DUNS Number, which is required, before seeking a new FDA Registration.

Days
Hours
Minutes
Seconds
LIMITED OFFER
FDA FOOD FACILITY
REGISTRATION
$99.00 | SERVICE FEE
FDA REGISTRATION RENEWAL IS REQUIRED FOR THE FOLLOWING COMPANIES

■ Food Facility

■ Dietary Supplements Facility

■ Food Canning Establishment

■ Drug Establishment

■ OTC Drug Establishment

■ Medical Device Establishment

■ OTC Cosmetic Establishment

You may want to take this opportunity to switch U.S. Agent, if your facility is in Canada, Mexico, Brazil, Australia, India, Pakistan, Russia, China, South Korea, Japan, Portugal, Spain, Italy, France, Belgium, Netherlands, Switzerland, Germany, Sweden, United Kingdom, Ireland.

And as expected, ITB HOLDINGS LLC makes the process easy, even for clients who speak only foreign languages.

FDA REGISTRATION SERVICES IN INDIA OR CHINA

Are you or will you be offering Food Facility Registration Services to local corporations?

Then, our discounts for multiple registrations can help you achieve your business goals. Your own clients will appreciate the additional savings.

IMPORT-EXPORT OF COVID-19 RELATED PRODUCTS

The United States spends $3.3 trillion per year on healthcare, which is more than the combined expenditures of China, Japan, Germany, India, United Kingdom, Italy, Brazil, Canada, Russia, South Korea, Spain, Australia, Mexico, Indonesia, the Netherlands, Saudi Arabia, Turkey and Switzerland ($3.24 trillion).

Therefore, exporting your personal protective equipment (PPE) or hand sanitizers to its market makes sense.

However, you must first register your establishment with the U.S. Food and Drug Administration (FDA), and list your products.

User Fee of $5,546.00 is required for Medical Devices Establishment Registration (Fiscal Year 2021).

User Fee of $20,322.00 is required for OTC Drugs  Establishment Registration.

User Fees are paid to the U.S. Treasury. You must first have an account.

Also, have your company’s DUNS Number ready, when you contact ITB HOLDINGS LLC.

LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
OVER-THE-COUNTER (OTC) DRUGS
$350.00 | SERVICE FEE
  • Alcohol Hand Sanitizers
  • Alcohol Wipes
  • Sunscreens
LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
MEDICAL DEVICES (PPE)
$350.00 | SERVICE FEE
  • Facemasks
  • Surgical Masks
  • N95 Respirators
  • Gowns, Face Shields, Gloves, Goggles
Contact ITB HOLDINGS LLC

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    FDA REGISTRATION
    SERVICE FEE?
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