The NUVISAN site in Berlin is currently offering opportunities to conduct investigational in vitro studies assessing the genotoxic and mutagenic potential of suitable candidates. In addition - at present – dose-range-finding studies in rats under non-GLP conditions are offered.
This package encompasses the entire service deck, including in-life phase, clinical pathology, histopathology and toxicokinetic evaluation.
From late Q3/2021 onwards NUVISAN strives to expand their experimental portfolio under a GLP certificate offering in vitro genotoxicity evaluations utilizing the bacterial reverse mutation assay (according to OECD 471, ICH S2R) as well as the micronucleus test (according to OECD 487, ICH S2R). Furthermore, in vivo toxicity studies in rodents will be offered in accordance with regulatory requirements (ICH M3 (R2) and further ICH Safety Guidelines) in due course.
Controlling and toxicological assessment of impurities is mandatory in drug substance development. We can support you on :
To deliver high-quality solutions to our clients, we adhere to high standards for the development and manufacturing of your medicines: