Method Validation

Do you want to convince the authorities and auditors that your method is valid?

We apply the ICH guidelines for method validation.
Our validations are customised services. Mix and match between:

  • Validation protocol including setting acceptance criteria
  • Verification of method suitability
  • Verification of the method accuracy and precision, and repeatability
  • Robustness (including intermediate precision)
  • Conclusions about compliance with acceptance criteria
  • The Validation report includes all documentation

All our procedures are compliant with the ICH guideline:  Q 2 (R1) Validation of Analytical Procedures: Text and Methodology (europa.eu)  and will be customised for each specific technique. We define robustness, repeatability, accuracy, suitability, linearity, LoD and LoQ

Let’s Help!

Dr. Fozia Shah, Project Manager

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