CSV Life Science will be your guide in this journey.
CSV Life Science Q&C department
Our Q&C department will help you achieve nitrosamine regulatory compliance by taking a structured approach to risk assessment, analysis, and confirmatory testing.
There are more and more requirements imposed by the authorities concerning nitrosamines. They’ve established a several step process for MAHs where pharmaceutical companies were advised to avoid nitrosamine in human medicines.
Have you already planned a re-prioritization activity in compliance with authority requirements?
Do you have the suitable resources for planning all the confirmatory testing activities?
WHAT WE CAN OFFER
qualified expert support for risk assessment
in case of risk identification, planning and organization with appropriate Analytical Laboratories of all experimental activities, up to variation of MA
Download our guide and discover how we can help you!