ICH M10 is the new guide for the validation of bioanalytical methods which was adopted by ICH last year and has been implemented by EMA in January 2023. Our Bioanalysis department, working with the Quality Assurance Unit, has adapted their LC-MS/MS methods to the new guide, and starting from that date, their validation studies and sample analysis comply with these new ICH M10 requirements.

The ICH guideline harmonizes and builds upon previous guidelines from the US FDA and EMA, ensuring that the drug development and­­ clinical trials bioanalytical studies are conducted in accurate and reliable manner. This new guide facilitates the establishment of a unified standard across all the health authorities from around the world, and it simplifies the process of conducting bioanalytical studies and ensures compliance with global regulatory requirements.

Since our adaptation to this new guideline, we have received very positive feedback from our clients about this new version of validation protocols and sample analysis protocols, confirming the compliance of our methods and procedures with ICH M10.

If you need more information about this new guideline or any assistance with your projects, please contact quotes@kymos.com. We will be pleased to provide you with detailed consulting and support.