U.S. FDA Regulatory Support
Professional Guidance for Your U.S. Market Entry
Contact ITB HOLDINGS LLC for practical assistance with FDA registration, U.S. Agent representation, FSVP, medical-device importing, labeling and other compliance matters involving products shipped to the United States.
- Foreign manufacturer support
- Multiple regulated industries
- Clear next-step guidance
Contact Our Regulatory Support Team
Include your company name, product category, manufacturing country and requested service so your inquiry can be reviewed efficiently.
Send your company information, product description and regulatory question.
United States
Speak with the team regarding FDA compliance and U.S. import support.
United Kingdom
International telephone access for companies outside the U.S.
U.S. Office
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
Common Reasons to Contact Us
Regulatory support is tailored to your product, facility role and intended method of entry into the United States.
FDA Registration
Registration, renewal, listing and related assistance for eligible food, supplement, cosmetic, drug and medical-device businesses.
U.S. Agent Service
United States-based representation for qualifying foreign facilities that must identify an agent during FDA registration.
Import Compliance
Support involving FSVP, medical-device Initial Importer service, Importer of Record planning and shipments to U.S. warehouses.
Labels & Records
Practical review of labels, records, certificates and compliance documentation before products are offered in the U.S. market.
Multilingual Support for Foreign Companies
Assistance is available in Spanish, German, Dutch, French, Italian, Portuguese, Chinese, Japanese, Korean and other languages.
Ready to Discuss Your FDA Compliance Needs?
Send your company and product details today, to begin identifying the registrations your U.S. market plan may require: Conventional food | Dietary supplements | Canned food | Medical devices including sunglasses | Prescription drugs | OTC drugs including hand sanitizers | Conventional and OTC cosmetics including sunscreens.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
info@fda.itbhdg.com
Monday-Sunday
3:00 AM – 6:00 PM, EST