The Fraunhofer ITEM offers contract research in the area of human health, with an emphasis on the respiratory tract as a target organ. The focus is on toxicity testing, pre-clinical registration studies, early-phase clinical trials, and chemical risk assessment. Many different test systems are available, including in vitro, ex vivo, and in vivo models. Research activities and services offered range from studies in the areas of occupational and environmental toxicology and consumer protection to pre-clinical and clinical drug research and development, including also GMP process development and manufacturing of biopharmaceuticals for clinical trials. All studies can be performed in compliance with GXP regulations.