Identification of alerting structures and functional groups associated with mutagenic potential using expert knowledge systems.
Quantitative structure-activity relationship predictions using validated computational models for genotoxicity assessment.
Integration with expert knowledge for final classification and determination of acceptable limits per ICH M7 guidelines.
Make early, informed calls that save time, reduce cost, and protect your development program.
Screen impurities computationally before committing to lab studies. Minimize unnecessary Ames test experiments, save weeks of testing time, and focus resources only where experimental confirmation is truly needed.
Identify mutagenic risks early in development. Prevent late-stage impurity surprises, avoid costly reformulation or rejected batches, and strengthen your overall control strategy.
Structured classification aligned with regulatory expectations. Transparent rationale supporting each impurity assessment with reduced risk of regulatory questions or objections.
Ensure your assessments meet expectations from the U.S. Food and Drug Administration and European Medicines Agency. Built to reflect how regulators evaluate mutagenic risk under ICH M7.
Establish TTC-based limits where applicable, support specification setting and justification, and enable faster progression to clinical and regulatory milestones.