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Analytical Method
Development and Validation

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Comprehensive Method Development and Validation

Our analytical method development and validation services provide clients with reliable, high-quality methods that are essential for accurate testing and regulatory compliance. We offer a range of validation services to suit different project needs.

Ensuring Accuracy, Efficiency, and Compliance

Analytical Method Transfer

Comparative analysis to ensure consistency and accuracy during method transfer.

Reduced Analytical Method Validation

Streamlined validation for existing methods that require minimal adjustment.

Full Analytical Method Re-validation

Comprehensive re-validation to maintain accuracy and regulatory compliance.

Optimization and Customization for Enhanced Performance

Pharmadox specialises in optimising existing methodologies to enhance throughput and efficiency. We identify critical method attributes and perform rigorous validation in accordance with European Pharmacopoeia (Ph. Eur.) and International Council for Harmonisation (ICH) guidelines, ensuring each method meets the highest standards.

  • Method Optimisation: Improving efficiency and throughput for faster results.
  • Critical Attribute Identification: Ensuring method reliability and regulatory alignment.
  • Compliance with Ph. Eur. and ICH: Adhering to international standards for quality and safety.

Nitrosamine Method Validations

With nitrosamine analysis now a critical requirement in pharmaceutical testing, Pharmadox Healthcare is equipped to deliver precise detection and validation services. Our advanced GC-MS/MS and LC-MS/MS systems enable accurate nitrosamine analysis in APIs and finished products, ensuring full compliance with regulatory standards.

Precision Testing for Nitrosamine Detection in Pharmaceuticals

  • Advanced Detection Systems: GC-MS/MS and LC-MS/MS for nitrosamine testing.
  • Compliance Assurance: Meeting international guidelines for nitrosamine safety.
  • Product Safety Focus: Ensuring all products are safe and free from harmful impurities.

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