Pharmaceutical manufacturing
Legal and technical requirements for manufacturing companies.
A pharmaceutical manufacturer optimized its production processes as part of the expansion of its product portfolio. We supported the quality assurance (QA) and the responsible person (FvP) in the development of the concept in legal and regulatory matters.
Legal and technical requirements for manufacturing companies
A pharmaceutical manufacturer optimised its production processes as part of an expansion of its product portfolio. We supported quality assurance (QA) and the responsible person (FvP) in developing the concept with regard to legal and regulatory issues, ensuring that all product-specific requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS). For this purpose, we also systematically reviewed internal guidelines (Standard Operating Procedures, SOPs) and compared them with regulatory requirements (guidelines and technical interpretations). This strengthened quality awareness and consolidated quality documentation.
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.
From A to B via CH
International distribution of medicinal products
An internationally active pharmaceutical company based in Switzerland handles the Europe-wide distribution of its medicinal products from Switzerland. The task was to clarify the conditions under which direct deliveries between EU countries with administrative processing via Switzerland are possible and...
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.