Successfully mastering inspections (GxP)

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.

From A to B via CH

International distribution of medicinal products

An internationally active pharmaceutical company based in Switzerland manages the Europe‑wide distribution of its medicinal products from Switzerland. The key questions were under which conditions direct deliveries between EU countries with administrative processing via Switzerland are possible and which authorisations are required for this purpose.
All players in the pharmaceutical supply chain must comply with the principles of good manufacturing practice (GMP) and good distribution practice (GDP) in order to protect patients from falsified medicinal products entering the legal supply chain. Drawing on our experience in Swiss and European pharmaceutical law as well as in matters relating to the bilateral agreements (Mutual Recognition Agreement, MRA), we were able to contribute to the design of the distribution structure.