Overview

Smarter the electronic Common Technical Document (eCTD) publishing Software, smoother will be the eCTD submission process. It all depends on how effective an eCTD software is to create, validate, track, publish, view, and manage the entire documentation lifecycle inclusive of complete clinical/pre-clinical research data. In addition, the functionality to be considered is the eCTD Software’s adoptability to region-specific submission formats under strict eCTD guidelines and compliance timelines. It might be time consuming at times to manage or convert the existing data into different region-specific eCTD templates / submission formats like:

Investigational New Drugs (INDs)
New Drug Applications (NDAs)
Abbreviated New Drug Applications (ANDAs)
Marketing Authorization Applications (MAA)
New Drug Submission (NDS)
Abbreviated New Drug Submission (ANDS)
Drug Master File (DMF)
Active Substance Master File (ASMF)
Investigational Medicinal Product Dossier (IMPD)
Biological License Applications (BLAs)
EAEU Electronic Submission

In such scenarios, apart from the accuracy of the data that is required to submit, life sciences organizations should also look for a robust and effective eCTD tool / publishing & submission software for faster, compliant and seamless submissions. With advanced eCTD software – PRO – effectively handles clients’ end-to-end global publishing and submission requirements.

Our software also supports EAEU’s (Eurasian Economic Union) electronic submission format. It is one of the first electronic submission software to support and implement electronic submissions in the EAEU region.

PRO Expertise

Solution Highlights

  • Collaborative submissions, preparation and review
  • Health Authority query management
  • Flexibility to integrate with leading eDMS
  • Effective and automated validation of each user activity via electronic signatures
  • Meticulous reporting
  • End-to-end submission tracking
  • Automated global eCTD templates
  • 21 CFR part 11 compliant
  • Inbuilt Validator
  • Inbuilt eCTD Viewer
  • Inbuilt PDF Manager
  • Import Utility
  • Module Cloning
  • Cross Reference Functionality
  • Robust audit trail & reporting mechanism
  • A web-based eCTD software/li>
  • Lightweight, Flexible and Robust
  • Milestone tracking feature
  • Advanced notification system

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