Analytical Development

Our team of researchers develops innovative and cost-effective methods and technologies. With the support and advice of our Regulatory and Quality people, we approach your CMC issues with agility, timeliness and thoroughness.

Method development

We develop methods from scratch or we can optimize your existing analytical methods. Among others, we develop: 
  • Stability indicating HPLC and UPLC methods (Drug Substance and Drug Product) that are specific for degradation products resulting from manufacturing, storage and/or stress conditions (heat, pH, light, oxidation)
  • Residual solvent GC methods
  • Dissolution methods with sufficient discriminating power, taking into account biopharmaceutical and formulation factors
  • Assay and limit tests
  • Physicochemical tests
Method validation 

All methods are validated according to ICH guidelines.

Contact us for more information

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