Dossier

We Richberg Healthcare have expertise in regulatory consulting and dossier solutions for export registration. We write and review dossiers as per guideline.

CTD

  •  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)

ACTD

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

Country Specific

DMF (Open and Closed Parts)

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

BE Studies.

Technical Documents:

  • Analytical Method Validation/Verification (AMV).
  • Comparative Dissolution Profile.
  • Stability Studies with summary reports.
  • Expert Quality Report, Clinical and Non-clinical.
  • Summary of product (SmPC) and Pack Information Leaflet (PIL).
  • Art Work.
  • Clinical Trial Studies from DCGI approved labs.
  • Reply to Ministry of Health (MOH) queries.
  • Approvals/Products Permission/FSC.