“KB International performed a facility GMP audit at our unit in Hungray, and we were very pleased with the report provided. It was comprehensive, practical and clearly indicative of what was actually missing and what an FDA inspector would look for in 21 CFR 820. We are appreciative of the level of service we received at very reasonable rates.”

“I’m really pleased with the service and support I received from KB International. The team has clearly identified the device classification and made the necessary modification in the naming as per FDA Product Code. They helped us to complete the registeration and listing with USFDA within 14 working days.”

“I’ve worked with KB Intl, Hungray for the technical file preparation of our medical device with an ancillary drug. The team involved was technically sound, friendly & cooperative. The team used a cloud-based software, so that all developments were timely discussed and corrected. This helped us to close the project before schedule.