Pharmaceutical product development
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Analytical Services

The amount of analytical chemistry activities to support pharmaceutical development continues to grow. Analytical measurements are needed to monitor processes, quantify impurities and assay products throughout a drug’s development from pre-clinical to commercial phases.

Analytical capability and understanding is now more important than ever in achieving successful analytical programs, good methods and appropriate specifications.

How can PDS help ?

PDS can help you cope with the ICH Quality requirements and help implement analytical strategy for both legacy and new APIs and drug products:

  • Method development and validation
  • Impurities analysis – related substances, degradants and qualification
  • Stability testing and data interpretation
  • Analytical method transfer
  • Quality control
  • Specification setting

Specialities

  • Chromatographic separation methods
  • Genotoxic impurities analysis
  • Answering agency questions and provision of expert technical advice
  • Quality by Design analytical methods
  • Gap analysis of analytical methodologies and validation packages