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.