Viewer for dossiers

Unlock and explore the true value of your regulatory dossiers in a safe and secure, web-based eCTD viewer.

Login
With a local account

Learn more

We believe that viewing matters! Do You?

Import Submissions

Import dossiers and submissions stored in your own safe document repository. Automatically enrich them with metadata to unlock the true value of your information assets. Optionally add your custom attributes by configuration only.

Explore across Dossiers

Gain and maintain control over your data and move from a dossier centric approach to a holistic view across products and regions. Dossplorer eCTD viewer offers unique views on regulatory activities, merged views across branches and integrated views across multiple products

Personalized navigation tree

Personalize your navigation tree utilizing metadata already present in your dossiers. The tree configurator allows users to change the hierarchical organization of dossiers. View settings, expanded nodes and selected metadata are stored and available after re-login.

Dossier formats supported

Dossplorerâ„¢ is an eCTD viewer, NeeS viewer and supports viewing any file and folder structure. This allows you to import virtually any regulatory dossier, including medical device dossiers, CTA dossiers, Paediatric Investigation Plans (PIP) and Investigational Medicinal Product Dossiers (IMPD).

Dossier review

Collaborate and add comments to eCTD, NeeS and other dossiers. Dossplorer can be used to support your internal review workflows, eCTD life cycle management and submission publishing.

Unique views on eCTDs

Collaborate and add comments to eCTD, NeeS and other dossiers. Dossplorer can be used to support your internal review workflows, eCTD life cycle management and submission publishing.

Advanced restrictions

Limit access by applying advanced node restrictions to sequences or sections within a dossier. This provides the option to restrict specific contents such as non-blinded clinical study data or confidential details about quality and manufacturing to a limited group of users.

Automated import

The automated import agent scans for new dossiers and sequences published on the connected network locations. Submissions are imported automatically upon detecting them. Dossplorer only stores references to the files and will not duplicate the physical content files.

Hybrid-cloud or full on-premise architecture

With the hybrid connection architecture the web application will be deployed in MS Azure but the users connect via VPN to the document depository on the internal network of the user. A full on premise installation is also possible.

Contact

Personalized demonstration of Dossplorer eCTD viewer?