Who Is FDABridge? The Miami-Based FDA Compliance Company Built for Foreign Manufacturers

FDABridge is a United States-based FDA regulatory compliance company headquartered in Miami, Florida — one of the largest international trade and import-export hubs in the Western Hemisphere. We exist for one reason: to make it possible for any manufacturer anywhere in the world to export their products to the United States legally, correctly, and without unnecessary delay. We handle FDA facility registration, DUNS number acquisition, US Agent designation, food labeling compliance, MoCRA cosmetic facility registration and product listing, drug establishment registration, NDC labeler codes, and every other regulatory filing that stands between a foreign manufacturer and the US market.

Why Miami matters for FDA compliance

Miami is not an accident. It is the single largest air cargo hub in the Americas, the primary port of entry for food, cosmetics, and pharmaceutical imports from Latin America, the Caribbean, and increasingly from Asia, the Middle East, and Africa. More FDA-regulated products pass through Miami International Airport and PortMiami than almost any other entry point in the United States. Our physical presence in this import-export corridor means we understand the operational reality of getting products through US customs and FDA review — not from a textbook, but from daily proximity to the process. When a shipment is held at the port, we are not in a different timezone trying to send emails. We are local to the infrastructure that determines whether your product reaches the US shelf or gets sent back.

What FDABridge actually does

We provide end-to-end FDA compliance services for foreign manufacturers who want to export food, beverages, dietary supplements, cosmetics, over-the-counter drugs, or medical devices to the United States. Our core services include: FDA Food Facility Registration (FFR) for manufacturers, processors, packers, and holders of food products. DUNS number acquisition and verification — the unique facility identifier that FDA now requires and actively enforces. US Agent designation — every foreign facility registered with FDA must have a US-based agent, and we serve as that agent for thousands of facilities worldwide. MoCRA cosmetic facility registration and product listing — the new mandatory FDA filing requirement for all cosmetic manufacturers selling in the US market. Drug establishment registration and NDC labeler code acquisition for OTC drug manufacturers. Food label compliance review — we review ingredient lists, nutrition facts panels, allergen declarations, and net quantity statements against FDA regulations before your product ships. Prior Notice filing for every shipment entering the United States.

Part of a larger accredited organization

FDABridge is not a standalone startup. We operate as the international trade compliance arm of an organization that holds ISO/IEC 17021 and ISO/IEC 17065 accreditation — meaning our parent organization is qualified to certify management systems and products against international standards. This accreditation is not something you can buy or fake. It is earned through rigorous third-party assessment and ongoing surveillance. What this means for our clients is that our understanding of manufacturing, quality systems, food safety, environmental management, and occupational health is not theoretical. We come from a background of auditing factories, reviewing processes, and certifying management systems across dozens of industries and dozens of countries. When we review your FDA registration or your food label, we are applying the same depth of knowledge that goes into certifying a factory against ISO 9001 or ISO 22000. We know every EA code, every NACE sector, every industry classification — because our parent organization covers one of the widest accreditation scopes in the certification industry. That is why we understand your product category, your manufacturing process, and your regulatory exposure better than a generic consulting firm.

Local agents in your country, in your language

FDA compliance is complicated enough without a language barrier. FDABridge maintains local representatives and agents in the countries where our clients operate. When you contact us, you speak to someone in your language — not a chatbot, not a generic call center, not an automated form. We have native-language support covering Turkish, Arabic, Spanish, Portuguese, Vietnamese, Indonesian, Chinese, Hindi, French, German, Japanese, Korean, Thai, Urdu, Bengali, Malay, Filipino, and more. Our local agents understand your country's export infrastructure, your banking system, your shipping routes, and the specific challenges that manufacturers in your region face when trying to reach the US market. This is a one-to-one service. You get a dedicated point of contact who knows your file, your products, and your timeline. When FDA sends a notice to your US Agent — which is us — we translate it, explain it, and act on it within hours, not days.

Premium services at prices that make exporting possible

We made a deliberate decision early on: FDABridge would not be a premium-priced service that only large corporations can afford. Our FDA Food Facility Registration starter package — which includes DUNS number acquisition, FDA registration, and first-year US Agent service — is priced at USD 449. Our MoCRA cosmetic registration package starts at the same price point. These are not stripped-down services. They include everything a manufacturer needs to be legally compliant for US export. We keep our prices low because our mission is not to extract maximum revenue from each client. Our mission is to make it possible for manufacturers everywhere to access the US market. A spice producer in Bangladesh, a cosmetics brand in Istanbul, a frozen food processor in Vietnam, a confectionery manufacturer in Ghana — they all deserve the same quality of regulatory support that a multinational corporation gets from a Big Four consultancy. We just deliver it at a fraction of the cost because we have built systems and processes that make it efficient, and because we believe that global trade should not be a privilege reserved for companies that can afford $50,000 consulting retainers.

The mission behind FDABridge

FDABridge exists because we believe that regulatory barriers should not prevent good products from reaching consumers. Every country has manufacturers who make excellent food, effective cosmetics, and quality consumer goods. Many of them cannot export to the United States — not because their products are unsafe or substandard, but because they do not know how to navigate FDA regulations, they cannot afford traditional compliance consulting, or they simply do not have access to reliable information in their language. We want to change that. We want every manufacturer who makes a good product to be able to sell it in the largest consumer market in the world. That is not a marketing slogan. It is the reason we built this company, the reason we keep our prices low, the reason we hire local agents instead of relying on email-only support, and the reason we answer the phone when you call. If you are a manufacturer anywhere in the world and you want to export to the United States, FDABridge will get you there. Visit fdabridge.com to see our services, or go to fdabridge.com/contact to speak with someone in your language today.