Secure Cloud-Based eCTD and NeeS Dossier Viewer and Manager

Dossplorer™ functions as your own safe repository to import full application and individual submissions. Dossiers are automatically enriched with metadata extracted from the submission, which unlocks the true value of your information assets. Optionally, additional metadata can be added manually as part of the import process.

Dossplorer™ provides a holistic view across products and applications worldwide. As a result, users can create a consolidated view across dossiers in a single CTD structure. This allows for easy comparison of content and data present across multiple eCTDs.

You can personalize the navigation tree utilizing metadata already present in your dossiers. For example, the tree configurator allows you to change the hierarchical organization of dossiers. Moreover, the view settings, expanded nodes and selected metadata are stored and available after re-login.

Automatically translate individual documents or all documents in a dossier, sequence, or dossier section to 100+ languages and download them in DOCX or PDF format. Use case example: By translating and reusing the documentation for registered products for submission to other markets in other languages, medical writers can review and update the existing content rather than writing it from scratch

Dossplorer™ is an eCTD viewer, NeeS viewer and supports viewing any file and folder structure. Therefore, you can import virtually any regulatory dossier, including medical device dossiers, CTA dossiers, Paediatric Investigation Plans (PIP) and Investigational Medicinal Product Dossiers (IMPD).

You can review the dossier and add the comments to eCTD, NeeS and other dossiers. Likewise, Dossplorer™ can be used to support basic internal review workflows, eCTD life cycle management and submission publishing.

Dossplorer™ facilitates creation of current and cumulative views on individual regulatory activities and merge branches (e.g. 3.2.P branches for drug products or 3.2.S branches for drug substances) into a single branch. As a result, you can easily compare documents across different strengths, dosage forms and manufacturers.

Advanced node restrictions can be applied to sequences or sections within a dossier in order to limit the access. This feature allows you to restrict specific contents such as non-blinded clinical study data or confidential details about quality and manufacturing to a limited group of users.

Dossplorer™ Xchange Bot scans for new dossiers and sequences published on the connected network locations. Consequently, the import agent detects the submissions and import them automatically. Dossplorer™ only stores references to the files and does not duplicate the physical content files.

The hybrid cloud / on-site solution offers you cloud-based software as a service whilst keeping your data privately stored on-site or in a virtual private cloud. Alternatively, Dossplorer™ can be installed as a full on-site solution. User only needs a web browser such as Chrome or Edge to connect, without any local installation required.

Safe and secure access to Dossplorer™ can be facilitated with single sign-on applications, such as Okta, PingFederate, Microsoft 365.