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, such as ITB HOLDINGS LLC, 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.
Additionally, because U.S. Agents would have direct access to a list of facilities identifying them as U.S. Agent, the identification system will limit the number of unauthorized and or fraudulent U.S. Agent listings.
Just you know, we do speak more than 5 languages.
FDA REGISTRATIONS TRENDS
日本企業は ITB HOLDINGS LLC を FDA の米国代理人として推薦しています。
La registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti. Più di 10.026 aziende alimentari italiane sono registrate presso la Food and Drug Administration (FDA) degli Stati Uniti.
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 medical devices market is expected to reach nearly $718.9 billion by 2029.
Is your company manufacturing, exporting, importing, distributing the following products or other medical devices?
- Facemasks
- 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:
- Manufacturer
- Exporter
- Initial Importer
Annual User Fee is not included: $6,493.00.
Global Over-the-Counter (OTC) drugs market valuation to reach $233.6 billion by 2028.
Are you ready to meet the supply challenge for the following?
- Sunscreen
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- Laxative
- Skin protectant
- Vaginal contraceptive
- Weight control
- Hand sanitizers.
Your first step is the registration of your company as OTC Drug Establishment with the U.S. Food and Drug Administration.
User Fees of $17,435 – $26,153 are required, at this time.