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Reducing the complexity of viewing and reviewing electronic submissions
All regulatory submissions start their life as a number of discreet documents and fragmented metadata. These are formed into a structured submission before being validated, published, and transmitted to the authorities. This is a long and complex process involving many different stakeholders, working with multiple types of content, using a variety of systems, over an extended period of time. Needless to say, working together on these can be incredibly complex and time consuming.
EXTEDO eSUBmanager improves the collaborative viewing and reviewing process surrounding submission content and metadata in readiness for transmission to the publishing system.
- Save time identifying multiple dossiers of interest, by easily searching on metadata
- Centralized overview of regional submissions compiled by local
- Optimized simultaneous collaboration between publishers and
reviewers via in-progress submission access
- Effortlessly view submissions with full lifecycle support
- Do you see what I see? – 35 regulatory agencies worldwide use
- Supports global regulatory standards including EAEU as well as legacy
versions of eCTD
- Available as inhouse or hosted solution
One consolidated view from multiple sources
The structure of an electronic submission like eCTD is highly complex and tightly governed. eSUBmanager delivers a unified view of all folders, documents, and metadata that form submissions and applications, enabling users to quickly visualize their content. An application located on a connected common file system together with its content can be browsed instantly.
Comprehensive collaborative reviews
Using its web-browser based viewer, eSUBmanager allows your staff to quickly read and mark-up any documents within a submission directly without the need to have specific editing software installed.
Its integrated viewing technology streams only the requested sections of content directly to a viewer’s web browser, enabling optimized viewing and mark-up without the need to download the entire document. In addition, its collaborative mark-up tools enable suggestions to be made and shared in real-time, without requiring direct edits on the original content.
Improved dossier management
During production, documents are added into the submission structure from numerous master sources. Typically, these systems are separate from the main submission management platform and host their own preparatory structures. If not properly controlled this can mean that structures differ, and updates between the systems is a manual user process. This can result in a delay and can be highly error prone, especially when update rates are high.
Using eSUBmanager, your regulatory management staff, as well as other interested groups within your company, can review the entire structure of submissions using just their web browser.
Planning the path ahead
In addition to content in production it is highly likely that there are numerous documents that you know will have to be written, but at this time are not in a position to create. Using future eSUBmanager document placeholders, it will be possible to insert planned content into the submission structure before it is authored. Placeholders contain meta-information about the forthcoming document, or section within the submission, to enable regulatory affairs, operations and managers to instantly identify content that needs to be completed before a submission can be finalized.
User experience is key
Built with simplicity at its heart eSUBmanager takes away the burden and let’s you concentrate on what’s most important – high quality dossiers.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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