Our clients around the world are mostly startups, small and medium-sized enterprises (SMEs).
However, more multinationals are joining us.
- Import-Export Companies
- Contract Manufacturers
- Medical Device Suppliers
- App Developers
- Fulfillment by Amazon Sellers
- Warehouses
- OTC Drug Manufacturers
We’re excited to learn about your company, and help you expand your market.
Just you know, we do speak more than 5 languages.
FDA REGISTRATIONS TRENDS
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
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 or other medical devices?
- Facemasks
- N95 Respirators and Surgical Masks
- Face shields, isolation gowns, goggles, gloves
- Portable Dental Equipment
- Dental hygiene disinfection systems
- Catheter
- Computer-Assisted Surgical Systems
FDA USER FEE is not included.
The Global Over-the-Counter (OTC) Drugs market is anticipated to reach $274.15 billion by 2026.
OTC drugs that are regulated by the U.S. Food and Drug Administration through Monographs include:
- Sunscreen
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- Laxative
- Skin protectant
- Vaginal contraceptive
- Weight control
- Hand sanitizers.
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.
ITB HOLDINGS LLC offers assistance to domestic and foreign firms.