Regulatory dossiers contain comprehensive and detailed information about pharmaceutical products. Since they serve as the primary source of truth for regulatory agencies to assess safety, quality, and efficacy, they play a crucial role in the regulatory approval process.
This valuable information, however, remains hidden from the users. In their day-to-day operations they often rely on various systems to access regulatory content. The main challenge lays in the fact that the data and the documents are in different systems and there is a disconnect between them.
Dossplorer™ saves dozens of hours for regulatory teams by eliminating process inefficiencies, ZIP file downloads and extractions, and multiple review steps.
We are prepared to help pharmaceutical companies transition to the new eCTD version Learn more about eCTD 4.0
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.
Follow self-guided demos of Dossplorer™ to see how our cloud-based eCTD viewer simplifies global dossier access, review, and collaboration—anytime, anywhere.
PowerSearch™: Find any data across your global dossiers
Across Dossiers View
Instant Document Translations.
Personalized Navigation Tree
Compare Versions & Documents
Complete Dossier Translation Solution
Collaboration Features: Review, Add Comments to eCTD, NeeS & Other Dossiers
Unlock and explore the true value of your regulatory dossiers, NeeS & other regulatory dossier formats in a safe and secure, web-based eCTD viewer.
Option to perform search both on content and metadata values
Search within search results
Option to display a snippet from documents to provide context
Ability to filter the search results based on a module or a CTD section
Use of advanced logical operators for search
Built-in user guide with use cases
Ability to track documents submission status and quickly identify and filter out documents which have been approved by the health authorities
Ability to narrow down the search results using dynamically adjustable metadata filters
Automatic ordering of search results based on relevancy
Export of search results
Imagine you want to do a regulatory impact assessment, like one of the below; how long would it take you today?
How is regulatory impact assessment carried out using the Dossplorer™ PowerSearch™ Module?
11 Nov, 2025
04 Nov, 2025
23 Oct, 2025
21 Oct, 2025
08 Oct, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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