We ensure your food, beverage, supplement, cosmetic, drug or medical device meet every U.S. Food and Drug Administration (FDA) standard, giving you the freedom to trade globally, and grow your brand or startup.
Serving International and U.S. Clients
▪ Multilingual Support
▪ Fast Response Times
FDA Compliance doesn’t have to be confusing. Our team helps you understand what’s required, how long it takes, and how to avoid common mistakes.
Ready to Export, Import or Stay FDA-Compliant?
Many businesses choose professional assistance to save time and money. Contact our Compliance Consultants, today.
FDA Compliance • Import Support • U.S. Market Entry
Professional FDA Compliance Services for Companies Entering the U.S. Market
ITB HOLDINGS LLC helps foreign manufacturers, exporters, global suppliers, online sellers, and U.S. importers prepare for FDA registration, labeling, FSVP, and inspection readiness.
Who We Work With
We support food, dietary supplement, cosmetic, OTC drug, and medical device companies seeking to sell products in the United States through importers, distributors, Amazon, Shopify, TikTok Shop, Facebook, and other e-commerce platforms.
Why Companies Choose
ITB HOLDINGS LLC
Companies choose us for practical regulatory guidance, clear documentation, fast response, multilingual support, and compliance strategies designed for real-world import, marketplace, and FDA inspection requirements.
Our Core Services
FDA food facility registration, U.S. Agent services, FSVP compliance, label review, MoCRA cosmetics support, medical device establishment registration, importer documentation, and FDA inspection readiness.
Food & Beverage Compliance
We help food and beverage startups meet U.S. and international regulations quickly and affordably.
Navigating FDA requirements doesn't have to be complex. We manage the essentials for you: Facility Registration, Compliant Labeling, Prior Notice, Foreign Supplier Verification Program (FSVP).
Cosmetics Compliance (MoCRA & OTC)
We simplify FDA Establishment registration, product listing, U.S. Agent service, safety substantiation, label reviews (Ingredients, Warnings, and Claims), and Good Manufacturing Practice (GMP) implementation.
Drug Regulatory Services
From FDA registration to label and ingredient review, we help drug companies launch safely.
Supplement
Dietary supplements include vitamins, minerals, herbs, and other nutritional products.
Our comprehensive FDA compliance strategy covers every critical pillar of the regulatory process, including facility registration, labeling reviews, Prior Notice submissions, and full GMP (Good Manufacturing Practice) implementation.
Medical Device
Guidance through FDA requirements, eMDR submissions, and global registrations.
Medical devices range from simple tools to advanced diagnostic equipment. FDA oversight depends on device classification and may include establishment registration, device listing, and premarket submissions.
Overview
This overview helps determine how FDA classifies your product and which regulatory pathway applies. Proper classification is critical to avoiding enforcement actions, shipment refusals, or product bans.