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, IMPD, CTA, eNTA, VNeeS 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.
Simplify lifecycle management of pharmaceutical submissions
EXTEDO's eCTDmanager, including its available modules, simplify all areas related to the lifecycle management of pharmaceutical submissions. Once an eCTD-based dossier has been approved by the agency, its post-approval maintenance lifecycle starts. eCTDmanager provides you with unique visual and contextual aids to ensure rapid response and accuracy.
Intuitive user interface: handling of pharmaceutical submissions without the knowledge of XML-technology
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).
eCTDmanager includes a sophisticated replication mechanism that provides globally distributed workgroup users with simultaneous access to a submission. Especially for global acting companies with subsidiaries in other countries, this functionality is a tremendous benefit. In combination with DOCmanager, which allows the creation and maintenance of many child dossiers based on one parent dossier, the solution will be even more effective. eCTDmanager can be easily integrated into document management systems such as:
- Ainea™
- CSC FirstDoc™, CSC FirstPoint™
- EMC Documentum™
- IBM SCORE™
- MasterControl™
- Microsoft SharePoint 2007 and 2010™
- NextDocs™
- OpenText™
- Optimal Systems™
- QUMAS DocCompliance™
- 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 and grow to integrate with your 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
- cross links
- powerful management of hyperlinks
- resolution of external hyperlink
- hyperlinks to bookmarks
- automated text to hyperlink functionality that supports most technical writing standards
- handling of named-destinations
- hyperlink source view enables to view the source and target of a document simultaneously
- hyperlink review functionality that allows approval of hyperlinks
- Capability to clone submissions
- EU eCTD DTD version upgrades
- Reuse of submissions for other regions
- Sophisticated replication facilitates allowing collaborative working in globally distributed workgroups
- Integrated tracking functionalities for dossiers
- Management and generation of Study Tagging Files
- Flexible filename handling that conforms to ICH and regional filenames
- Business Validator for FDA, Canada, CH (Swissmedic approved) and EU (EMA approved)
- Interim documents for paper publishing and compilation that allow compilation without having the final document ready
- Publishing Service (optional) publishes paper and electronic submissions locally in an global environment
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)