Studies on residues, toxicology, environmental fate and ecotoxicology typically rely on the accurate determination of active substances and/or their metabolites in various matrices. Current EU legislation requires a full validation of the analytical methods and specifies the respective criteria.
Accordingly, correctly and fully validated analytical methods and their clear reporting according to the requirements of current EU guidelines are fundamental to the success of any registration. This includes the new SANTE/2020/12830 superseding SANCO/3029/99 + SANCO/825/00 but also SANCO/3030/99, SANTE/12682/2019 and OECDENV/JM/MONO(2007)17.

Over the years, our regulatory analytical methods specialists have gained extensive experience in assessing analytical method validation reports, monitoring analytical method validation and physico-chemical property testing studies, coordinating 5-batch analyses and writing technical equivalence assessment reports. We prepare the analytical methods and physico-chemical properties sections of registration dossiers in compliance with current EU legislation for the registration of plant protection products and active substances. We also evaluate and reply to authority requests, compile expert statements and devise up-to-date strategies and solutions.