Hermann Lehn, PhD, is a well known and worldwide acknowledged quality assurance professional with more than 25 years of international real-world experience in the nonclinical/GLP/GCLP quality business of Big Pharma. During his rich career at Bayer AG in Germany and F. Hoffmann-La Roche AG in Switzerland, with leadership responsibilities at the respective US sites, he has developed a strong network with business and QA professionals within the pharmaceutical industry and contract research organizations (CROs).He has a strong track record in quality assurance and in the outsourcing of toxicology studies to CROs.
His main areas of expertise are developing, maintaining and overseeing quality processes in non GxP-regulated research laboratories, in GLP facilities and in laboratories which analyze samples (biomarkers, bioanalytics, hormones,,,) from clinical trials according to GCP regulations. A unique strength is his deep insight into the global CRO marketplace, based on his oversight of several hundred CRO inspections for GxP compliance, having done many of them by himself, and on the technical and scientific capabilities of many CROs, due to his former role as outsourcing manager. From 1988 on, he has attended in different roles at several GxP inspections from GLP Monitoring Authorities from Germany, from Switzerland, and from the US which makes him an expert for preparing and supporting customers in case of inspections by GxP Monitoring Authoritities.
LehnConsulting was founded in June 2015 with the ambition to deliver effective, high quality services and pragmatic business solutions.