The QM Company was established by Katharina Kurpanek, a former GCP inspector at the German Federal Institute for Drugs and Medical Devices [BfArM].
Katharina has over 19 years of professional experience in clinical research and development. She can provide clients with a combination of operational experience (having worked for a CRO and a global pharmaceutical company) and regulatory expertise (6 years as a GCP inspector). It enables Katharina to provide her clients with a unique insight in regulatory requirements in this highly regulated industry while ensuring that the advice provided is pragmatic.
Katharina disposes of an established network within industry and regulatory authorities (Europe and USA). She is an active member of the DIA, and former chair of the DIA GCP&QA Community.