We provide comprehensive services to dietary supplement manufacturers, distributors and brand owners.
Dietary Supplements
We provide comprehensive services to dietary supplement manufacturers, distributors and brand owners. Together, you will get the resources to not let FDA regulatory compliance get in the way of your business.
Facility Registration – Register your Supplement Facility
Label Review & Claims – Perfect your labels and analyze your claims
If you are considering bringing a medical device to the U.S. market, we make the FDA compliance portion of your journey easy.
Medical Devices
If you are considering bringing a medical device to the U.S. market, we make the FDA compliance portion of your journey easy. By saving valuable time and resources, you will be able to focus on the more important parts of your business.
Facility Registration & Product Listing – Obtain Facility Registration and List your devices
Device Classification – Classify your device / Determine your premarket obligations
Premarket Notification (510k) – Get Your Device Cleared / Clear Your Device for Market
Label & Claims Review – Get you Device labels right
U.S. Regulations Require All Food Facilities (E.G., That Manufacture, Process, Pack, Or Hold Food, Beverages, Or Dietary Supplements For And Food Facilities Located Outside The United States Must Designate A U.S. Agent.