Although your U.S. company does not need a U.S. Agent, your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment, is required to appoint one as part of the registration process.
What a U.S. Agent is not?
- Commercial Agent
- Customs Broker
- Initial Importer
- Importer of Record
- FSVP Importer
Our consultants serve both domestic and international clients.
FDA will not complete a registration, or provide a registration number, until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.
Just you know, we do speak more than 5 languages.
Monday – Sunday
3:00 AM – 6:00 PM
Eastern Standard Time
Get a faster response to your questions and concerns.
Usually same day or less than 30 minutes if you provide full company name, physical address and telephone number.
T: +44 800 610 1577
REGISTER YOUR FOOD FACILITY
The global personal protective equipment (PPE) market is expected to reach nearly $13.2 billion by 2027.
Is your company manufacturing, exporting, importing, distributing the following products, instead?
- N95 Respirators and Surgical Masks
- Face shields, isolation gowns, goggles, gloves
- All other medical devices
The following establishments must be registered with the U.S. Food and Drug Administration:
- Initial Importer
Annual User Fee is required and extra: $6,493.00.
Global Hand sanitizer market valuation to reach $17.2 billion by 2026.
The growth is primarily attributed to rising prevalence of COVID-19, supportive regulatory scenario which promote the use of the product, and increasing awareness pertaining to personal hygiene.
Are you ready to meet the supply challenge?
Your first step is the registration of your company as OTC Drug Establishment with the U.S. Food and Drug Administration.
User Fees of $16,119 – $24,178 are required, at this time.