Did you know that the United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a presence in the US to appoint a registered US FDA Agent? It’s not just a regulatory obligation; it’s an opportunity to ensure seamless communication with the FDA and maximize your success in the US market.

Why choose RABT Global as your US FDA Agent?

Professional Representation: Our dedicated team specializes in medical devices and IVDs, providing you with top-notch regulatory support worldwide.

·        Prompt and Confidential Service: Count on us to handle all your regulatory responsibilities professionally, confidentially, and efficiently. We prioritize your interests as an independent “third party” representative.

·        Global Reach: With representation services available in 5+ international markets, we can be your trusted in-country representative across multiple regions.

·        In-Country Offices: Unlike most consulting firms, RABT Global maintains employee-staffed offices in Germany, France, UK, India, Japan, Australia, Canada, and other countries. Rest assured, you can easily reach out to our local experts.

·        Establish Professional Representation: We understand the importance of having a dependable regulatory firm to represent your company. Partnering with RABT Global as your US FDA Agent is a small price to pay for securing your professional presence in the US.

Act Now: Contact us today to ensure compliance and success in the US market!

Common questions about US FDA agent representation:

What is an Official Correspondent? The Official Correspondent is the person identified in the establishment registration that the FDA contacts first in case of an issue. While the Official Correspondent doesn’t have to be located in the US, appointing Emergo as your Official Correspondent ensures effective handling of inquiries from FDA officials, guaranteeing smooth communication.

Why choose a professional regulatory firm over a distributor? Distributors excel at selling products but lack expertise in regulatory matters. By partnering with RABT Global, you have a dedicated team that prioritizes your interests. We ensure your compliance with FDA regulations and can guide you through any incidents or transitions, providing peace of mind.

Don’t miss out on the US market potential! Contact RABT Global today to appoint us as your US FDA Agent and unlock success in the world’s largest medical device market.