GLP analysis of dosage forms used for toxicology studies

  • Development and validation of analytical methods
  • GLP analysis of dosage forms used for toxicological and safety pharmacology studies

Analytical development and support for formulation development

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  • Development, pre-validation and robustness of analytical methods
  • Forced degradation and pre-stability studies
  • API/excipient compatibility
  • Analytical support for formulation development and process robustness
  • Establishment of monographs for NCEs and herbal drugs

Validation and Transfer

  • Validation of analytical methods
  • Analysis for cleaning and process validation
  • Design and interpretation of analytical method transfers and robustness studies
  • Experimental design (DOE) and statistical interpretation

Stability studies

  • Stability studies on drug substances and finished products (including clinical batches)
  • On-going stability studies
  • In-use stability studies, cyclic temperature stress studies, photostability
  • Extractables/Leachables studies (packaging)

Micellaneous

  • Identification of impurities by GC/MS or LC/MS/MS
  • Assay of genotoxic impurities (according to CPMP/SWP/5199/02)