GLP/GCP Laboratory for Bioanalysis and Pharmacokinetics
As an Independent GLP/GCP testing laboratory we analyse biological samples delivered mainly from pre-clinical and clinical studies. For this purpose we develop and validate analytical methods according to the newest guidelines. With our state of the art equipment (e.g.¬†HPLC, HPLC-MS/MS, ELISA)¬†we detect small and¬†large molecules as well as biomarkers.
Our service comprises consultation during the preparatory stage of a study.¬† We support our customers in¬†the planning of both pre-clinical and clinical studies considering study design and other pharmacokinetic parameters. Study results are evaluated with Phoenix WinNonLin¬†and documentation is delivered¬†according to the existing Guidelines (FDA/EMA).
We gladly assist our clients with pharmaceutical analyses. We can rapidly provide you with reliable information on an active substance and examine its purity and content independent of the material it is delivered with. In addition, we¬†offer all kind of stability investigations.
We quantify according to GLP nucleic acids in various biological matrices for you. We develop standardized and reproducible methods that will bring you through FDA/EMA registration.