Effortlessly view submissions with full lifecycle support and workflows
Save time identifying dossiers of interest, by easily searching on metadata
Supports global regulatory standards and legacy versions of eCTD
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.
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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.
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.
“EXTEDO is a great example of a company that really understands the requirements of the market.”
Director Business Development, Technical Operations and international Business at Genericon
Your plan to effortless compliance
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Manage your regulatory submissions centralized from anywhere
Improve the collaborative viewing, reviewing and tracking process surrounding submission content and metadata in readiness for transmission to the regulatory authorities
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.
Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite.
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.