The overall aim of the OSMOSES project is the further development of the “Open Systems Pharmacology Suite” (OSPS, http://www.open-systems-pharmacology.org/), a modeling & simulation software platform, to prepare for future needs by increasing efficiency in model management and qualification. OSMOSES will solve two major challenges in PBPK/PD and complex systems modeling & simulation, namely 1) the requirement for continuous (re-)qualification of PBPK & QSP models throughout their life-cycle and 2) handling the growing complexity of the developed models. This is to be achieved by 1) further developing the OSP automated (re-) qualification framework and by 2) improving the methods and tool functionalities for model building, modularization and management.