Analytical determinations within the scope of clinical studies according to Good Clinical Practice (GCP) or for registration studies in Europe (EMA) or USA (FDA), require an SOP system and documented workflows that comply with the regulations according to GCP and GCLP. Therefore, we validate our analytical assays for use in humans according to the guidelines of the ICH, FDA, and EMA. In addition, the laboratory equipment and installations meet the requirements that are generally intended for analytics in a regulated environment. Thus, the ACL is able to perform drug analysis in pivotal studies according to GCP and GCLP.

Background

Publications/Links