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
- 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