
FDA Bridge
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Overview
2 - 9
Employees
2023
Year Founded
ABOUT FDA BRIDGE
Quality
FDABridge assists foreign manufacturers and exporters with the registration of their products with the U.S. Food and Drug Administration (FDA). We focus on helping food producers, cosmetic brands, and pharmaceutical manufacturers from countries such as Vietnam, Indonesia, Saudi Arabia, UAE, Colombia, Mexico, India, and over 30 others. Navigating the FDA registration process can be complicated due to intricate requirements, strict deadlines, and a challenging portal—especially for companies where English is not the first language. FDABridge is here to alleviate that challenge. Our clients inform us about their products and target markets, and we take care of the rest. Our services include FDA Food Facility Registration, FDA Cosmetic Facility Registration under MoCRA, Drug Establishment Registration, representation as a U.S. Agent, acquisition of DUNS and FEI Numbers, NDC Labeler Code, drug and cosmetic product listings, label reviews, and EU Responsible Person assignment for the European market. FDABridge is run by an internationally accredited conformity assessment body with ISO 17021 and ISO 17065 certifications, operating a licensed office in Miami, Florida. We have successfully assisted manufacturers from Southeast Asia, the Middle East, Latin America, and Europe in registering with the FDA and starting their exports to the United States. Our offerings include transparent pricing, quick turnaround times of 3 to 5 business days, and comprehensive compliance management. We proactively reach out to our clients before each renewal deadline, ensuring they never miss an FDA requirement. Our clients only pay once a year and can forget about FDA paperwork entirely.
LANGUAGES SPOKEN
English
HIGHLIGHTS
2 - 9
Employees
2023
Year Founded
Services
Focus
Industries
Clients
Services Provided
69% Maintenance Services
20% Drug Establishment Registration
11% Registration Services
About the Team
OUR STORY
Navigating the heavily regulated US food market requires foreign manufacturers to comply with the Federal Food, Drug, and Cosmetic Act, enforced by the FDA through rigorous processes. To legally export food products to the US, foreign facilities must first obtain a DUNS number, then complete FDA food facility registration, including designating a reliable US Agent to facilitate communication and compliance. Additionally, precise adherence to detailed labeling standards and timely submission of Prior Notice before shipment arrivals ensures smooth entry at US ports. FDABridge offers comprehensive services managing these critical steps—from DUNS acquisition and registration to label review and ongoing maintenance—helping foreign food exporters confidently meet FDA requirements and successfully enter the US market.