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Viewing matters for eCTD, NeeS and other regulatory dossier formats

Dossplorer™ allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them from any location. Unlock and explore the true value of your regulatory dossiers in a safe and secure, web-based eCTD viewer. The hybrid cloud/ on-premise solution offers you cloud-based software as a service whilst keeping your data privately stored on-premise or virtual private cloud. Alternatively, Dossplorer™ can be installed as a full on-premise solution.

Learn more about Dossplorer™ benefits

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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 utilising the metadata already present in your dossiers. The tree configurator allows users to change the hierarchical organization and group dossiers by default attributes (including dosage form, manufacturer, excipient, product or product group) according to their needs.

Dossier formats supported

Dossplorer™ 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

Next to traditional views on eCTD you can create current and cumulative views on individual regulatory activities and merge branches (e.g. drug product, drug substance) into a single structure. This allows you to easily compare documents across different strengths, dosage forms and manufacturers.

Multi-Browser Compatibility

The responsive design of the user interface and adherence to formal web standards allows for support by all commonly used browsers such as Google Chrome and MS Edge and access the eCTD viewer via desktop, laptop, smart phone or tablet.

Multi Tenancy

The multitenant architecture offers a dedicated share of the application for every user. Physical and virtual resources are dynamically assigned and reassigned according to consumer demand, whilst the database is installed and maintained on premise to offer optimum balance between flexibility and security.

Document security

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. You control your own policy on secure access of confidential dossiers from any location and by third parties.

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