Tag: us-market-entry
What Makes a Good U.S. FDA Agent (And What to Watch Out For)
If you’re a foreign manufacturer selling into the U.S., you already know you need a U.S. Agent. It’s not optional, FDA requires it for food, drug, cosmetic, and medical device facilities based outside the country. What a lot of companies don’t realize until they’re already signed up is that “U.S. Agent” isn’t a standardized service.…
What Is FDA Prior Notice and Why Does It Matter for Your U.S. Shipment?
If you’re exporting food, beverages, or animal feed to the United States, you’ve likely encountered the term Prior Notice. Missing this requirement, or getting it wrong, can stop your shipment at the border, leading to costly delays and product destruction. Here is what you need to know to keep your cargo moving. What Is Prior Notice?…
Top 10 Questions About FDA Registered Agents — Answered
Use this 8-step FDA compliance checklist to avoid costly shipment delays and ensure your products enter the U.S. smoothly.
Navigating FDA Requirements: Establishment Registration Explained
If your company is based outside of the United States, the FDA has one more requirement during that registration process: you need to name a U.S. Agent.