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.
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.
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.
Import Dossiers in Dossplorer™ eCTD Viewer
Explore Across Dossiers
Personalized Navigation Tree
Review, Add Comments to eCTD, NeeS & Other Dossiers
CCDS solution
New solution/module, which enables automated comparison of information in one or more CCDS documents in whole or in part (per sections). Users in a dedicated role have an option to import CCDS documents. All standard Dossplorer functions such as search, translations, and version comparison is applicable to the CCDS documents as well.
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
Use of advanced logical operators for search
Automatic ordering of search results based on relevancy
Search within search results
Built-in user guide with use cases
Export of search results
Option to display a snippet from documents to provide context
Ability to track documents submission status and quickly identify and filter out documents which have been approved by the health authorities
Ability to filter the search results based on a module or a CTD section
Ability to narrow down the search results using dynamically adjustable metadata filters
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?
Product Owner, Technology SME
Kosta is an experienced IT professional based in the Netherlands, with over 12 years of specialized expertise in managing and implementing IT solutions for the pharmaceutical industry, including business-critical applications, such as RIMS, Submission and Publishing, and DMS.
As Product Owner at Celegence, Kosta oversees the continuous development and validation of innovative proprietary software applications. He is committed to delivering high-value solutions through agile methodologies, ensuring that business requirements are effectively translated into technical solutions.
He holds a Master's degree in Business/Managerial economics from the University of Zagreb.
Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier, a Celegence company. Besides supporting customers through Regulatory Affairs consulting, she is also action as the Celegence Netherlands site head.
Marloes’ areas of expertise are: regulatory affairs (both HQ and affiliate focused), biopharmaceuticals (incl. biosimilars) development, regulatory convergence & harmonization, facilitated registration pathways (incl. orphan drugs), eCTD publishing and lean authoring.
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Associate Director of Regulatory Operations and Publishing
Maikel Bouman is our Associate Director of Regulatory Operations and Publishing, with 8 years of industry experience.
He has broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation, and dispatch of different types of electronic submission formats to various regulatory authorities across the Americas, Europe and Australia.
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25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
25 Apr, 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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