Establish Defensible Limits for Product Quality

Residuals of starting materials, intermediates, and degradation products can introduce impurities that compromise the safety of drug substances and products. Setting scientifically sound impurity limits is a mandatory aspect of pharmaceutical development. SAXOCON ensures your product meets the highest quality and safety standards by providing the rigorous data required for regulatory acceptance.

SAXOCON provides the end-to-end expertise required to establish and document Permitted Daily Exposure (PDE) in full compliance with international requirements, including:

• Mutagenic Impurity Classification:
  Categorization via ICH M7 using advanced (Q)SAR and read-across methodologies.
• Organic Impurity Profiling:
  Categorizing impurities according to ICH Q3A, Q3B, and Q3C frameworks.
• PDE Derivation:
  Establishing Permitted Daily Exposure based on the specific methods and principles outlined in ICH Q3C.
• Elemental Impurity Control:
  Expert management of elemental impurities in accordance with ICH Q3D, as well as European and US Pharmacopoeias.

Why Choose SAXOCON?

Our impurities evaluation services provide the technical assurance needed for high-stakes submissions:

• Deep Regulatory Knowledge:
  Extensive experience in state-of-the-art safety assessments that align with the latest international standards and guidelines.
• Computational Precision:
  Best-in-class expertise in (Q)SAR modelling and read-across methods to identify risks without unnecessary testing.
• Strategic Efficiency:
  Smart, cost-effective strategies that prioritize the data regulators demand, accelerating your timeline to market.

Delivery

SAXOCON compiles all necessary evidence into a comprehensive expert report for your New Drug Application or Marketing Authorisation Application. Our deliverables are specifically designed to fulfil ICH Q3A, Q3B, Q3C, Q3D, and M7 requirements, ensuring a seamless path to approval.