Join our clients around the world: mostly startups, small and medium-sized enterprises (SMEs). Import-Export Companies Contract Manufacturers Medical ...
Companies must verify that the food they are importing into the United States has been produced in a manner that meets applicable U.S. food safety sta...
Your next FDA Biennial Registration Renewal is between October 1 and December 31, 2022. When you are competing with 300,000+ companies to renew your F...
All plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation must be under the supervision of...
Insulin manufacturer prices are higher in the U.S. than those in each of 32 other high-income countries. Consequently, Americans are likely paying fou...
FDA has the authority to ban a medical device intended for human use if it finds, on the basis of all available data and information, that the device ...
Unlike drugs, dietary supplements are not intended to treat, diagnose, prevent, or cure diseases. That means, dietary supplements should not make clai...
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission t...
ITB HOLDINGS LLC as your company’s FDA U.S. Agent for: Cosmetic Establishment Registration Drug Establishment Registration Medical Device Establishmen...
Selling unapproved and misbranded hydrogen-infused water beverage products as drugs for use in treating or preventing COVID-19 and other diseases? ITB...