Secure Product Safety Across Your Lifecycle

Regulatory frameworks require pharmaceutical manufacturers to maintain strict control over product quality attributes throughout their entire lifecycle. According to ICH Q7, Q8, and Q9, any change, deviation, or non-conformance must be evaluated to ensure it does not adversely impact patient safety. SAXOCON provides the toxicological oversight necessary to manage these changes effectively while maintaining a state of Good Manufacturing Practice (GMP).

SAXOCON provides the specialized expertise required to evaluate the safety impact of manufacturing shifts, including:

• Data Synthesis:
  Exhaustive searching, reviewing, and summarizing of available toxicological data to support change justifications.
• Predictive Gap Filling:
  Utilizing (Q)SAR and read-across methodologies to fill critical data gaps without the need for new animal testing.
• Hazard Identification:
  Identifying major toxicological risks, including substances with genotoxic or carcinogenic potential.
• Clinical Safety Evaluation:
  Assessing the specific safety concerns for patients treated with drug products affected by process deviations or material changes.

Why Choose SAXOCON?

Our change management services provide the technical continuity needed to protect your production pipeline:

• Lifecycle Safety Experts:
  Extensive experience in state-of-the-art safety assessments that align with the highest international standards.
• Computational Precision:
  Best-in-class expertise in using (Q)SAR modelling and read-across methods to predict toxicological effects with high confidence.
• Regulatory Agility:
  Smart, cost-effective test strategies designed to satisfy regulators and keep your products on the market without interruption.
• Multidisciplinary Support:
  A team that bridges the gap between manufacturing engineering and toxicological safety.

Delivery

SAXOCON compiles all findings into a definitive Toxicological Risk Assessment Report. This document provides the rigorous scientific evidence required to fulfil GMP requirements and justify manufacturing changes to global health authorities.