Studies may be needed to evaluate whether food or feed ingredients could have negative effects on the health of animals, humans or the environment. Deciding whether a study is necessary for safety reasons or can be waived requires a scientific approach to regulatory affairs.
Identification of data requirements, analysis of currently available data for compliance with regulatory requirements, definition of missing information and development of study plans.
Design studies for target animals, consumers and users to meet regulatory requirements, request offers from reputable study facilities, monitor and interpret studies to ensure compliance
Assist in the design, monitoring and evaluation of in vitro and in vivo toxicity trials to demonstrate safety. This includes: genotoxicity, acute, sub-chronic, chronic and reproductive toxicity trials
Scientific assessment of absorption, metabolism, degradation and excretion pathways of a substance. Design and monitoring of required studies and environmental exposure calculations
If you would like some support to evaluate whether studies are required or would like assistance in selecting a testing facility and planning a compliant trial, please feel free to contact us.
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