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

Switch U.S. Agent, then pay the lowest FDA Registration Service Fees

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FDA FEES

A fee can be charged by any professional who is providing special services like a lawyer, accountant, dentist, doctor, architect or freelancer.

The rate is decided by the professional and is partially or fully paid in advance. Some professionals also charge a fee on an hourly basis,  while others charge based on the entire service.

What does a professional services agreement cost? You may ask this question if you need to hire an experienced consultant.

Under the Flat Fee structure, consultants provide their clients with a fee quote, and they will not incur additional expenses.

This last option is the only one offered by ITB HOLDINGS LLC, and all fees are listed online, so there are no surprises.

FDA REGISTRATION SERVICE FEES

When you contact ITB HOLDINGS LLC and request any of its several services, an invoice will be sent, unless payment was made online. Most fees are annual.

FDA FOOD FACILITY SERVICE FEES
Clear Filters
Canned Food
$350.00
Dietary Supplements
$99.00
Food Label Review
$99.00
Prior Notice
$25.00
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FDA COSMETICS, DRUGS, MEDICAL DEVICES SERVICE FEES
Clear Filters
Drug Establishment
$350.00
OTC Cosmetics
$350.00
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While User Fees are expected to increase every year, ITB HOLDINGS LLC’s Service Fees will remain the same, and the lowest.

So, why pay more for less? Perhaps, this is your chance to switch U.S. Agent.

FDA REGISTRATION USER FEES

Some registrations require additional User Fees paid directly to the U.S. Treasury at the time of the registration, then between October 1 and December 31, every year for the following:

â–ª Medical Device Establishment.
â–ª Drug Establishment.

Animal Drug User Fee.
Animal Generic Drug User Fee.
Biosimilar User Fee.
FSMA Reinspection and Recall User Fees.
Device Facility User Fee (DFUF).
Generic Drug User Fee Amendments (GDUFA).
Medical Device User Fee Amendments (MDUFA).
Prescription Drug User Fee Act (PDUFA).
Over-The-Counter Monograph Drug User Fee Program (OMUFA).

FDA has partnered with the U.S. Department of the Treasury to utilize a Web-based payment application, for online secure electronic payment. It takes 2-3 business days to process online payments and 7-10 business days to process wire transfers and check payments, then for your Payment Confirmation Number (PCN) to be assigned.

The Food and Drug Administration uses DUNS numbers to uniquely identify foreign organizations, and the Employer Identification Number (EIN) for U.S. companies.

CONTACT ITB HOLDINGS LLC