In medical device and structural heart vale industry Biocompatibility, Tissue of Animal Origin, Sterilization, Viral inactivation qualification, EDQM certification, Regulatory submissions and Quality and Compliance is of utmost important. We provide testing and consulting support in all of these areas.
We have the unique talent of testing, consulting and strategizing services in the area of Biocompatibility, Microbiology, Viral Inactivation and Chemical Analysis. Our specialty is customizing the testing required based on the device not recommending the whole "nine yards of testing" for any device thus avoiding the valuable $ and time resources for our clients.
Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing to provide cost and time saving strategies whether it is a simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical device. Our consultants come with an in-depth knowledge with many years of experience. We offer customized solutions to each our clients on an as needed basis with utmost integrity.
- CONTRACT MANUFACTURING ORGANIZATION (CMO)
- CONSULTING SERVICES
- TESTING SERVICES