Identify and Control Mutagenic Risks with Expert Precision

The synthesis of drug substances requires reactive chemicals, reagents, and catalysts that can leave residual impurities in the final drug product. To limit potential carcinogenic risk, the ICH M7 guideline provides a rigorous framework for identifying, categorizing, and controlling these mutagenic impurities. SAXOCON delivers fully compliant assessments using state-of-the-art computational tools and expert toxicological interpretation to streamline your path to regulatory approval.

SAXOCON provides the specialized computational and toxicological analysis required for ICH M7 compliance, including:

• Comprehensive Data Mining:
  Exhaustive database and literature searches for existing carcinogenicity and bacterial mutagenicity data.
• Dual-System QSAR Screening:
  Utilizing both expert rule-based systems (Genetox Expert Alerts Suite) and statistical systems (Statistical QSAR Model) to predict mutagenic potential.
• Validated Methodology:
  All assessments follow ICH M7 (R2) guidelines and OECD Principles for the validation of QSAR models.
• Integrated Analysis:
  A synthesized summary of all computational outputs, providing a clear starting point for impurity classification.

Delivery

Upon completion of the screening, SAXOCON facilitates a technical consultation to confirm the necessary expert opinions for your specific predictions. All findings are compiled into a quality-controlled Toxicological Assessment Report, providing the defensible evidence required for your regulatory dossier.