Kamondi Bioanalytical Consultancy GMBH

provide scientific and technical expertise, advice and guidance to address bioanalytical and regulatory challenges associated with the development of biotherapeutics. services · determine bioanalytical strategy and assay battery · co-ordinate method development, assay transfer, troubleshooting and validation · verify that methods and data are scientifically sound, accurate and meet necessary regulatory requirements · conduct pre-qualification audit · identify suitable cro partner and liaise between client and bioanalytical lab for contracted services · manage and troubleshoot client programs at cros · prepare report templates and provide report writing services · review contracts, method validation and sample analysis plans and reports · prepare specimen logistic plans for sample analysis · provide operational and scientific support for non-clinical, clinical and post-marketing bioanalytical activities in regulated environment (glp, gclp, gcp, clia) · integrated analysis of