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Our expert team is dedicated to assisting you in evaluating the safety of impurities that could potentially be present in your Active Pharmaceutical Ingredient and or final pharmaceutical formulation by conducting thorough assessments, we ensure the safety of the final product, which directly impacts the well-being of the patients who rely on it.
Among the services, we can provide you:

    • Permitted Daily Exposure (PDE) Assessment of Medicinal Products, Active Pharmaceutical Ingredients, intermediates, residuals of raw materials and impurities

 

    • Impurity Safety Assessment (ICH Q3A, ICH Q3B and ICH M7), Genotoxicity, Toxicity and Risk Assessment

 

    • Toxicological Risk Assessment of Leachables and Extractables (L&E) on finished pharma products and their packaging

 

    • Elemental impurities evaluation (ICH Q3D), Solvents evaluation (ICH Q3C), Genotoxicity, Systemic Toxicity and Risk Assessment of impurities in Medicinal Products
    • “In silico” predictions for Toxicology (Leadscope and several freely available tools run internally, via external collaboration access to other programs as DEREK and Sarah); interpretation of results and Expert Report by our ERT® (European Registered Toxicologist)

 

    • Investigation of Mode of Action and relevance for humans concerning toxicological effects

 

    • Assessment of N-nitrosamine impurities in Active Pharmaceutical Ingredients to derive the Acceptable Intake for chronic and non chronic exposure, according to international accepted guidelines and scientific publications

 

    • Environmental Risk Assessment of a medicinal product for human use according to ICH guidance

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