Dossier & DMF


    Lifescience Intellipedia is a global leader in regulatory consulting and dossier solution for export registration. We write and review dossiers as per guideline.


  • Module-1 (Regional & Administrative Information)
  • Module-2 (Quality Overall Summary)
  • Module-3 (Quality)
  • Module-4 (Nonclinical Study Reports- Safety)
  • Module-5 (Clinical Study Reports- Efficacy)


  • Part I (Administrative Data)
  • Part II (Quality Summary)
  • Part III (Non Clinical Overview Summary)
  • Part IV (Clinical Overview Summary)


    Electronic version of CTD dossier accessed through the XML backbone.


    Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer with confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of API.

    Content of DMF

  • General Information
  • Manufacture
  • Characterization
  • Control of Drug Substance
  • Reference Standards or Materials
  • Container Closure System
  • Stability