Updating old files

Generika laboratory: validation of analytical methods

Mise-à-jour-des-anciens-dossiers-GENERIKA

  • New galenic development if necessary
  • Development and analytical validation of the active ingredients, preservatives, degradation products, antioxidants and chelating agents according to the international standards of the ICH
  • Drafting of the marketing authorisation files CTD Module 3 according to international standards ICH