We operate under an official manufacturing license issued by Swissmedic and are fully compliant with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. This certification underscores our commitment to quality, safety, and regulatory excellence throughout the entire production and supply chain. Our Quality Management team provides all necessary documentation, conducts essential review processes, and ensures ongoing compliance through regular audits and assessments. Additionally, Quality Management is responsible for organizing and overseeing staff training programs to maintain high standards of competence and regulatory adherence across all operations.
Our manufacturing infrastructure includes GMP-grade cleanrooms (Class A to D), in-house quality control laboratories, and dedicated process development labs. All necessary equipment and instruments required for the manufacturing process are readily available and maintained to ensure efficient and compliant production and quality control. This integrated setup ensures seamless development, production, and release of Medicinal Products in compliance with regulatory requirements.
Our dedicated Quality Control (QC) laboratory performs validated in-process controls to monitor and ensure product consistency during manufacturing. In addition, the QC lab conducts comprehensive release testing for final products, starting materials, raw materials, and consumables. The laboratory also carries out continuous environmental monitoring within the manufacturing areas to ensure compliance with cleanroom standards and maintain optimal production conditions. These rigorous testing and monitoring procedures guarantee that all materials and products meet stringent quality standards and regulatory requirements, ensuring safety and efficacy throughout the production process.
The strategy of Supply Chain Management is to ensure, by means of a risk-based approach, that suppliers, manufacturers and service providers used during production of clinical trial material at Wyss Zurich, comply with the corresponding GMP requirements.
Our established training programs and specialized coaching help project teams progress from research-focused groups to clinically ready teams. We provide the expertise and guidance needed to develop products that meet regulatory standards while fostering the skills for sustainable success. We work like a trusted development partner to support embedding a culture of quality and regulatory awareness within research teams to lay the foundation for reliable data, robust development processes, and successful clinical translation.
The Regenerative Medicine Platform unites Wyss Zurich’s experts, research teams, and start-ups working to translate innovative ideas into clinical and industrial applications. Together, we navigate the complex developmental processes that turn early-stage concepts into transformative therapies with real-world impact.
The Swissmedic Innovation Office offers individual on-site meetings to spin-offs and SMEs. This initiative is supported by the regenerative medicine platform and the Division for Business and Economic Development of the Canton of Zurich. The meetings aim to support and accelerate innovation projects. They take place in the premises of Wyss Zurich. The Business and Economic Development supports communication and promotion of the service.
Discover the projects that have been supported by the Regenerative Medicine Technologies platform, among others.
At Wyss Zurich, we help entrepreneurial teams from ETH Zurich and University of Zurich transform their projects in a real-world solution. Contact us to learn more about our application process.
