ELECTRONIC COMMON TECHNICAL DOCUMENT AND SUBMISSION TRACKING - S&T - vACT:eCTD™

INTRODUCTION:

The International Conference on Harmonization (ICH) has defined the Electronic Common Technical Document (eCTD) that describes the specification for the Globally acceptable electronic registration process from industry to regulatory authority. The Philosophy of the eCTD is to use an open standard, which includes its property standards.

The eCTD Submission system is designed to generate the Standards structure for selected products as per the ICH GuidelinesThe eCTD- Tracking system help to maintain track of all submission / pending for submission Products details

Feature List:

• Maintaining Master details i.e. Product, Country, Standards, Agents etc.
• eCTD Submission
  • Product Version Generation as per the Standards
  • Structure Generation as per Standards
    
  • Use XML / DTD as back bone for generation
• eCTD- Tracking
  • Submission tracking
    
  • Amendment Tracking
    
  • License tracking
    
  • Remainder facility
    
  • Query Maintenance
    
  • Product Status
    
  • Bio Study Tracking
    
  • Reports / Queries