Benefits

  • Improves submission quality and consistency
  • Reduces preparation and update time for original applications, variations, amendments, etc.
  • Fast access to documents and eCTD status for everyone involved in the project
  • Reduces paper and lowers logistics overhead
  • Supports parallel work locally and worldwide
  • Sophisticated management of hyperlinks and bookmarks
  • Improves process efficiency and reduces costs
  • Automatically build and edit Study Tagging Files (STFs)
  • Faster time to market
  • Easy to use MRP/DCP support
  • Integrated EMA approved validator (developed by EXTEDO)
  • Compliance with 21 CFR Part 11

eCTDmanager Suite

Comprehensive submission management solution

EXTEDO’s eCTDmanager is an off-the-shelf electronic submission management solution that satisfies your requirements for eCTD and non-eCTD submissions, whether electronic or paper.

eCTDmanager enables you to build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission structures easily. With its powerful hyperlinking and bookmarking engine, it helps you to handle the detection, notification and correction of broken hyperlinks resulting in the creation of high-quality submissions. An integrated validation function ensures compliance of the submissions to ICH and regional specifications.

With the eCTDmanager suite we are looking ahead to the future of electronic submission management: Prospective eCTDmanager solutions will be ready for new standards like Regulated Product Submission (RPS).

Simplify life-cycle management of pharmaceutical submissions

EXTEDO's eCTDmanager, including its available modules, simplify all areas related to the life-cycle management of pharmaceutical submissions. Once an eCTD-based dossier has been approved by the agency, its post-approval maintenance life-cycle starts. eCTDmanager provides you with unique visual and contextual aids to ensure rapid response and accuracy.

Automatically Build and Manage Study Tagging Files (STFs)

With EXTEDO eCTDmanager you can automatically build and edit Study Tagging Files (STFs).  The STF Wizard Window provides a fast and efficient way to create STF sections.  The STF Filetags View simplifies tag handling to save you time and avoid errors.  Additionally, the STF building feature allows for the automatic assignment of required metadata attributes as submission content files are added to the appropriate non-clinical and/or clinical sections of a submission.

Screenshot eCTDmanager

Easy to use

Even without the knowledge of XML technology, you can easily build and review submissions, add, edit and delete elements or even set hyperlinks and comments at any time during the submission compilation. Documents can easily be scanned, copied, moved or imported from the file system and from most Document Management Systems (DMS):

  • Ainea™
  • CSC FirstDoc™, CSC FirstPoint™
  • EMC Documentum™
  • IBM SCORE™
  • MasterControl™
  • Microsoft SharePoint™
  • NextDocs™
  • OpenText™
  • Optimal Systems™
  • QUMAS Compliance Platforms™
  • Veeva Vault™
  • others

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Functional overview

Management, submission component display, paper and e-paper publishing, and report management capabilities include the following:


  • Ability to start without using a document management system e.g. by using EXTEDO's document versioning module miniDMS, and grow to integrate with your future DMS
  • Advanced features for life-cycle management and control through functions like country filter
  • Advanced audit trail
  • Support of national and comprehensive approach for MRP/DCP procedures
  • Powerful hyperlink and bookmark capabilities
    • resolution of external hyperlinks
    • hyperlinks to bookmarks and named destinations
    • automated text to hyperlink functionality supporting most technical writing standards
    • hyperlink view for viewing source and target of a hyperlink simultaneously
    • hyperlink review functionality allows approval of hyperlinks 
  • Automated eCTD DTD version upgrades
  • Automated management and generation of Study Tagging Files
  • Support for parallel submissions
  • Easy reuse of submissions for other regions even with full life-cycle sequences
  • Sophisticated replication facilitates allowing collaborative working in globally distributed workgroups
  • Integrated tracking functionalities for dossiers
  • Flexible filename handling that conforms to ICH and regional filenames
  • Integrated Validator for FDA, Canada, CH (Swissmedic approved), EU (EMA approved), vNeeS
  • Supported regional eCTD standards: EU, FDA, CA, CH, JP, MCC, GCC/KSA
  • Support for eCopy format
  • Other supported standards: IMPD, CTA, NeeS
  • Interim documents for paper publishing and compilation and hyperlinking that allow compilation without having the final document ready
  • Publishing Service (optional) publishes paper and electronic submissions locally in an global environment
eCTDmanager logo

Available Modules

MiniDMS

Document version control

DMSconnect

Integration with leading document management systems

DOCmanager

Allows creation and maintenance of many child dossiers based on one parent dossier

RLPmanager

Report Level Publishing including lifecycle management

Publish Service

Global solution offering local eCTD, e-paper and paper publications.

Customer Quote

"CanReg has been using eCTDmanager software from EXTEDO since year 2005. We use this software to prepare all our eCTD submissions with U.S.A. FDA, EU EMA, individual EU Member States, and Health Canada. Since 2005 we submitted well over 1000 successful eCTD submissions for all major application types, including INDs, NDA/ANDAs, DMF/PMFs, MAAs and NDS/ANDS. No eCTD submission filed by us, ever received RTF or any negative feedback from regulatory agencies."

Ted Hanebach, Director Regulatory Operations at OptumInsight (formerly CanReg)