---

Let’s Break Down the Basics

Getting started with the FDA can feel like learning a whole new language, right? Two of the first terms you’ll hear are “Establishment Registration” and “Product Listing.”

Before we go any further, let’s be clear: this is not the same thing as getting “FDA approval.”

Think of it more like getting your business and your products on the FDA’s official roster. It’s a required step so they can keep a catalog of everything being sold in the U.S. market. This applies to pretty much everything the FDA regulates—from food, drugs, and cosmetics to medical devices and more.

So, Where Does a U.S. Agent Fit In?

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.

This is your official point of contact who is physically located in the United States. Think of us as your friendly liaison, your boots on the ground here in the U.S.

Our job is to be the bridge between you and the FDA. Specifically, we’re here to:

• Handle all communication: Any messages or requests from the FDA come straight to us. We make sure you get the information right away and understand what they need.
• Answer questions: If the FDA has questions about your products being imported, we’re here to respond.
• Help schedule inspections: When it’s time for an inspection, we’ll help you and the FDA coordinate to make the process as smooth as possible.

And here’s the most important part: legally, when the FDA tells us something, it’s the same as telling you directly. This means you never have to worry about missing a critical notice because of time zones or language barriers. We’re here to make sure nothing ever falls through the cracks.