Global Dossier Development

Global Dossier Development

  1. Advancing Existing Dossier with current Regulation
  2. Scale up of Existing National Dossier to CTD
  3. Scripting National CTD Dossier
  4. Build up of Regional CTD Dossier
  5. Evolution of Master Drug Dossier
  6. Scientific Review of CMC and BE data
  7. Strategic Input for Product Development

Global Dossier Development - Case Study

Read about the strategy we implemented to obtain common dossier development for Asia, Africa and Russia/CIS region