Mitigate Carcinogenic Risk and Ensure Compliance

Nitrosamine compounds are highly potent toxins, often considered carcinogenic at levels significantly lower than standard ICH M7 thresholds. Because these residuals can arise from complex interactions within starting materials, intermediates, or degradation processes, the EMA and FDA now mandate rigorous risk evaluations for all marketing authorization holders. SAXOCON provides the advanced toxicological depth required to identify these risks and establish defensible safety limits.

SAXOCON provides the specialized expertise required to navigate the multi-step nitrosamine review process, including:

• Step 1 Risk Evaluation:
  Comprehensive support for EMA/409815/2020 requirements, including assessing the impact of non-disclosed supply chain information.
• Potency Characterization:
  Expert assessment of carcinogenic potency using literature data, structural activity relationship (SAR) modelling, and read-across methods.
• Targeted Test Strategies:
  Designing and monitoring testing protocols that align with specific EMA and FDA expectations for drug substance and final product batches.
• Limit Derivation:
  Establishing scientifically sound, health-based limits, such as compound-specific Thresholds of Toxicological Concern (TTC).

Why Choose SAXOCON?

Our nitrosamine services provide the technical precision required for these high-scrutiny impurities:

• Computational Toxicology Leadership:
  Best-in-class experience using (Q)SAR and computer modelling to predict toxicological effects where experimental data is limited.
• Regulatory Authority:
  Extensive experience delivering safety assessments that satisfy the rigorous “Article 5(3)” review standards.
• Global Supply Chain Insights:
  The ability to evaluate risks from raw materials and intermediates through our extensive network of supplier data.
• Cost-Effective Compliance:
• Smart test strategies that prioritize high-risk areas, ensuring full alignment without unnecessary analytical overhead.

Delivery

SAXOCON compiles all findings into a definitive Toxicological Risk Assessment Report. This document is specifically engineered to fulfil EMA and FDA requirements, providing the technical evidence necessary to clear your product for market or maintain its current authorization.