eSUBmanager - View/Review eCTD Submissions and Track Submission Content

Reducing the complexity of viewing and reviewing electronic submissions.

Regulatory submissions involve different stakeholders, multiple types of content, and a variety of systems. Viewing and reviewing the different aspects of each submission is a complicated, yet critical undertaking without a single source of truth.

eSUBmanager is a browser-based reviewing software that offers a centralized overview of regulatory submissions with easy access from anywhere.

All regulatory submissions start their life as a number of discreet documents and fragmented metadata. These documents are created from multiple systems by different authors focusing on unique content before being compiled into a submission. Organizations who want to view and review the important files within a regulatory submission often find this challenging. After the compilation process, few tools are able to access and view individual files within submission compilations for review purposes.

EXTEDO eSUBmanager improves the collaborative viewing, reviewing and tracking process surrounding submission content and metadata in readiness for transmission to the regulatory authorities. As a centralized solution for the viewing and reviewing of submissions, users can view multiple types of documents, files and folders before publishing in eCTDmanager.

 

Benefits

A centralized overview of submissions via a browser.

Effortlessly view submissions with full lifecycle support and workflows.

Save time identifying dossiers of interest, by easily searching on metadata.

Supports global regulatory standards including EAEU and legacy versions of eCTD.

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. Applications located on a connected common file system together with its content can be browsed instantly.

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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. eSUBmanager enables 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. If not properly controlled this can mean that structures differ and require manual updates between the systems. This can result in delays and errors, 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.

Plan your content 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.

Resources

Services

Business Process and Regulatory Consulting Services

Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.

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