Toxicology

Accurate toxicological profiling of any new test item requires both solid routine expertise to meet regulatory requirements and flexibility to fit each project or investigate mechanistic issues.

NUVISAN offers a fully integrated (non-) GLP toxicity testing platform following all international standards (OECD, ICH, REACH, JMAFF, FDA & EMA guidelines). With the customized solution, we assess the safety of your lead compounds in a comprehensive & efficient way by the combination of various in vivo, in vitro, or analytical investigational methods.

(Non-) GLP Toxicology

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.

Safety Evaluations Impurities

Controlling and toxicological assessment of impurities is mandatory in drug substance development. We can support you on :

• Risk assessment and qualification strategies for impurities in drug candidates and drug products according to the ICH Q3 guidelines.
• Database & literature searches for genotoxicity and carcinogenicity data.
• In silico toxicology assessment using (Q)SAR methodologies to predict mutagenic potential according to ICH M7 guideline.