Secure Product Quality and Minimize Production Delays

The sudden discovery of particulate matter in or around drug products is a critical challenge in pharmaceutical manufacturing. Good Manufacturing Practice (GMP) and robust risk management require an immediate root-cause analysis and a comprehensive safety impact evaluation. This data is the deciding factor in whether to release a batch or initiate a recall. A predefined Service Level Agreement (SLA) with SAXOCON ensures you have a fast-track response team ready to manage deviations as they occur.

SAXOCON provides the rapid-response expertise needed to analyze and evaluate non-conformances, including:

• Accelerated Lead Times:
  Optimally stacked activities ensure a 2 – 3 week turnaround from the initial discovery to a final toxicological risk assessment.
• Root-Cause Identification:
  Advanced laboratory capabilities to quickly and accurately identify the source and nature of any findings.
• Sampling and Mitigation Strategy:
  Expert guidance on proper sampling techniques and immediate risk-mitigation steps.
• Toxicological Impact Analysis:
  A rigorous assessment of the safety implications of the findings to support your quality decisions.

Why Choose SAXOCON?

Our emergency response services provide the clarity needed to protect your brand and your patients:

• Multidisciplinary Rapid Response:
  Access to a team of highly skilled scientists and experts who specialize in manufacturing deviations.
• Regulatory Authority:
  Safety assessments delivered in full accordance with international GMP standards and regulatory guidelines.
• Decision Support:
  We provide the scientific evidence required to justify critical quality management decisions to stakeholders and regulators.

Delivery

SAXOCON compiles all findings into a definitive Toxicological Risk Statement. This document provides the technical justification needed for your quality department to confidently determine the fate of affected product batches.