• Discussion/Review of pharmaceutical development report (justification for the choice of composition, packaging, manufacturing process …)
  • Review of study protocols/reports for process validation (on pilots or industrial scale batches)
  • Review of Finished Product Specifications for release (routine controls) and for stability studies (until end of shelf-life)
  • Review of study protocols/reports for stability studies (ICH/VICH long term, In-use, Photostability, Freezing, Freeze-Thaw, Transportation …)