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The University of Zurich provides the full pipeline of medicinal products and medical devices development services from GLP, GMP to GCP under one roof.
The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system governing the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.
Innovative medicinal products and medical devices conceived and developed in academic environments, including the UZH, have proven successful for many years. However, promising inventions and products face a complex regulatory approval process as a final challenge before entering the market or being handed off to the industry.
The GLP quality management system ensures
of non-clinical laboratory (efficacy and safety) studies.
Reports generated from GLP studies are essential for obtaining the regulatory permissions necessary to starting clinical studies (when needed) and finally translating the newly developed medical products to industry and market. GLP promotes international acceptance of tests (mutual acceptance) and, hence, reduces time, costs and resources, thereby fulfilling the concept of 3R (reduce, replace refine) in animal testing. Academic innovations aren’t the only ones benefitting from university-based GLP testing capabilities. Many young biotechs with innovative treatment solutions are in need of high level academic expertise and the bespoke development of evaluation methods, which can only be achieved in academic innovative spaces, unlike the on-size-fits-all approaches of commercial testing services. Indeed, novel treatments often require novel testing frameworks, in compliance with quality management systems.
The GLP-RCU activities will set an internationally recognized and unique benchmark in translational research by accelerating approval by regulatory authorities (e.g., Swissmedic, ERA, FDA) of both biomedical products and drugs developed at the University of Zurich and thus address critical medical needs and improve health outcomes for animals and humans. The University’s GLP activities are currently being expanded by building on the GLP framework established at the Musculoskeletal Research Unit (MSRU) of the Vetsuisse Faculty, the MSRU already having been a member of the Swiss GLP compliance monitoring program since 2014, and integrating new units such as the Veterinary Diagnostics Laboratory (led by Prof. Dr. Regina Hofmann-Lehmann, Vetsuisse) and the Center for Preclinical Development (led by PD Dr. Paolo Cinelli, USZ).
To drive biomedical discovery and innovation by providing a state-of-the-art, GLP quality-assured environment at the UZH, adhering to and setting the highest ethical and legal standards, accessible to academia and industry partners.
