Dossier-Mgmt©

It is a web-based Submission Management Software that automates and seamlessly manages your dossier compilation process. It is designed specifically for the management of complex Submission life cycles using the ICH & as well as Region specific eCTD standard Guidelines. It provides concurrent access for the same drug product i.e. multiple users can work simultaneously on the same submission helping your team to adhere to the deadlines. Application can be used from any corner of the world using virtual private network and review of eCTD submission can be done by multiple users from multiple locations.

Ready-to-use Enterprise Version for Countries as per Latest Guidance as mentioned below:

  • US (FDA) eCTD
  • EU (EMA) eCTD
  • Canada (CA-HCSC) eCTD
  • South Africa (ZA-MCC) eCTD
  • Gulf Co-operation Council (GCC) eCTD
  • Australia (TGA) eCTD
  • Swissmedic (CH) eCTD
  • ASEAN
  • ROW- Brazil, Tanzania, etc

Salient Features:

  • Very simple, user friendly and Intuitive flow.
  • Import and life-cycle management of third-party eCTD Submission in Dossier-Mgmt©
  • Publish as Paper format OR Publish as NeeS format OR Publish as eCTD
  • Cumulative/ Consolidated view
  • PDF files properties verification + Correction
  • Insert TOC for the given bookmarks in PDF documents
  • Insert Bookmarks for the given hyperlinks in PDF documents
  • PDF file splitting [bookmark & page wise]
  • Multiple files uploading
  • In-built submission verification tool as per the guidelines provided by respective regulatory body
  • Menu level security and Submission level security
  • Audit trails along with Estimate File Size
  • Inherit / Copy contents from one submission to other
  • Elaborate Management Information System (MIS)