ABF is accredited according to
DIN EN ISO/IEC 17025 since 2004. All analytical methods are fully validated according to ICH M10 FDA Guidlines on Bioanalytical Method Validation and Study Sample Analysis, a comprehensive list of flexible accredited methods can be found
here. The bioanalytical methods are routinely run in compliance with the principles of
GLP and
GCP. Furthermore, the aspects of GCLP, as summarized in the EMA Reflection Paper, were taken into account in our laboratory procedures.
Our QM system is routinely audited internally as well as by external bodies such as the DAkkS, LGL or on the Sponsor's behalf. Our biomarker data were used to support numerous submissions to regulatory agencies.
ABF participates on a regular basis on external proficiency testing programmes. ABF was appointed as reference laboratory for numerous analytes by the “German External Quality Assessment Scheme” (GEQUAS).