- 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
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 $7,653 is required for the annual Establishment Registration (Fiscal Year 2024).
Some devices are subject to Premarket Notification 510(k) – Standard Fee: $21,760. Small Business Fee: $5,440 (Fiscal Year 2024).
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