Successfully mastering inspections (GxP)
A provider of therapeutic products services contacted Pharmalex GmbH as part of its periodic basic inspection. We advised them on the legal classification of the Swissmedic guidelines and technical interpretation as well as...
A provider of therapeutic products regulatory services contacted us as part of its periodic basic inspection. We supported the company in the legal assessment of Swissmedic guidelines and technical interpretations, as well as the GMP and GDP requirements under Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This allowed us to align the applicable GMP and GDP requirements with the existing quality management system.
Our advice focuses on pragmatic solutions carefully tailored to the client’s specific needs.