Method Development and Validation

Our experienced scientists can develop new methods for your products. These can be developed and validated to ICH guidelines which include the following parameters:

  • linearity
  • limit of detection (LOD)
  • limit of quantification (LOQ)
  • specificity (including stability of solutions)
  • precision (method, intermediate and system)
  • accuracy (recoveries)
  • robustness
  • forced degradation.

Our advanced instrumentation and expert knowledge helps to minimize time and costs involved in achieving detailed and reliable data. We perform trace level analysis and our approaches are suitable to identify physical and chemical properties of matrix and dosage forms.

Our method development and validation services cover each stage of product development and can be done from scratch or used to strengthen existing procedures. We also offer validation of existing procedures.

We specialize in understanding your requirements and delivering high quality results so please get in touch and one of our experts will respond as soon as possible.

Webinar Recordings:

» Perspectives on Extractables - Pharmaceutical Products and Medical Devices
» Update on USP Tests for Elemental Impurities - Are you ready?

Got a question?

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  • White paper

    Are you Ready for USP <232>/<233>?

    pdf 249 KB

  • Newsletter

    Pharmaceutical Newsletter

    pdf 418 KB

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