ITB HOLDINGS LLC’s Service Fees are the lowest for FDA Registration of your Facility or Establishment.
- Switch U.S. AGENT Deals
- No hidden costs
- No forced options
- Only what you need or want
- Reduced fee for multiple services
- Reduced fee for multiple companies
- U.S. Agent Service included
- Same Day Service for extra fee
Perhaps you noticed yourself that more companies are offering FDA Registration Services. How do you select one, since these professional services are certainly not free?
Using professional service providers to grow your business is not new. Attorneys, accountants, management and marketing consultants have specialized knowledge about niche areas that you couldn’t and shouldn’t hope to duplicate either personally or in the form of an in-house employee. Same applies to FDA Consultants.
Hiring outside consultants will allow you to do things you wouldn’t ordinarily have time for, and don’t want to hire permanent employees for. They can do them faster and more effectively than you ever could. Besides, your skills are needed in helping your business expand.
Beware of comparing one provider with another, on the basis of fees alone.
Service Fees are prepaid to ITB HOLDINGS LLC. There are no monthly invoices, here. You can cover the scope of the services to be rendered, the duration of the agreement and the fees by sending us an email message ou using the 24/7 Live Chat option.
You do not have to worry about fee schedule, whether fees are to be based on an hourly, daily or project rate, and who is responsible for paying expenses, because all our fees are publicly listed.
MORE PAYMENT OPTIONS, HERE
Debit / Credit Card, Bancontact, Giropay, iDEAL, Sofort, Apple Pay, Google Pay, SEPA Direct Debit, Stripe, Payments in multiple currencies.
- Company Registration
- U.S. Agent Service
Prior Notice, Label Review or Update, Foreign Supplier Verification Programs (FSVP), are available for extra fee.
Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE) and hand sanitizers, instead?
There are two types of fees here
- SERVICE FEES paid to ITB HOLDINGS LLC
- USER FEES paid to the U.S. Treasury
User Fees are required for the following
- Medical Device Establishment Registration
- Over-The-Counter Monograph Drug User Fees (OMUFA)
When you contact us, have your company’s DUNS NUMBER ready.
- Surgical Masks
- N95 Respirators
- Gowns, Face Shields, Gloves, Goggles
- Alcohol Hand Sanitizers
- Alcohol Wipes
- Skin Protectants
- Pain Relievers
FDA REGISTRATION requests must include:
- Full company name
- Complete physical address
- First and last name of CEO or Manager
- Email and telephone of CEO or Manager
- Product details
- Company DUNS Number
Data Universal Numbering System, DUNS or D-U-N-S from Dun & Bradstreet Inc. Free in 30 days or for a fee in 15 days.
Keep in mind that all domestic and foreign companies must have a DUNS Number. Therefore, requesting one now or as soon as possible, is in your company’s best interest.
FDA automatically performs a DUNS check during the registration process. So, make sure your company’s name and physical address match D&B’s records.
User Fees are paid to the U.S. Treasury.
Gowns, gloves, face shields, goggles, facemasks and respirators are Medical Devices. Therefore, an FDA User Fee of $6,493.00 is required for the annual Establishment Registration (Fiscal Year 2023).
Some devices are subject to Premarket Notification 510(k) – Standard Fee: $19,870.00. Small Business Fee: $4,967.00 (Fiscal Year 2023).
Over-The-Counter Monograph Drug User Fees (OMUFA) (FY 2023)
- Monograph Drug Facility (MDF) Facility Fee: $26,153
- Contract Manufacturing Organization (CMO) Facility Fee: $17,435
are now required to register an establishment manufacturing, among other products,
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- Hand sanitizers
The preferred payment methods are
- electronic check (Automated Clearing House – ACH also known as eCheck)
- credit or debit card (Discover, VISA, MasterCard, American Express).
Payment by credit card is available for balances less than $25,000.
An account is required. Contact ITB HOLDINGS LLC, first.
U.S. Department of Treasury
33 Liberty St
New York, NY 10045
Account Number: 75060099
Routing number: 021030004
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002
FDA’s Tax Identification Number: 53-0196965.
■ Biennial | October 1 – December 31, 2024