Search Regulatory Dossier Metadata & Content with Ease using PowerSearch™ – A Dossplorer™ Regulatory Submission Management Feature 

Regulatory dossiers contain comprehensive and detailed information about pharmaceutical products. Since they serve as the primary source of truth for regulatory agencies to assess the 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 located in different systems and there is a disconnect between them. The data is typically entered in a Regulatory Information Management System (RIMS) by data stewards, to a large extent typing in the same information which is already present in regulatory dossiers. The documents are managed in an eDMS system. To properly and efficiently manage regulatory changes users need access to both documents and data, and they need to be able to view the content in the context of their use.

‘Unlock the true value of regulatory dossiers to all stakeholders’ is the driving idea behind Dossplorer™. It’s advanced viewing capabilities allow users to quickly find and view desired content and all related metadata, whilst providing the ability to further enrich them.

To tackle all described pain points, Celegence developed the PowerSearch™ module which enables users to perform contextual searches across all global regulatory dossiers and utilize powerful filtering options on metadata.

This holistic solution can efficiently support our clients in their regulatory impact assessment during change control processes which positions Dossplorer™ as a true dossier management software and the go-to place for the single source of truth.

Below are the examples and use cases for regulatory impact assessment:

• Tightening of specification limits: Search for ‘’assay 90.0% specification’’ and in filters select the desired product
• Changes in components of the flavouring: Search for ‘’strawberry’’ and filter by desired Product and Country
• Change of packaging from blister to bottle for a Product: Select desired product(s) from the filter and search for ‘blister’ to check which documents and dossiers will be impacted by the change

• Option to perform search both on content and metadata values
• Ability to narrow down the search results using dynamically adjustable metadata filters
• Search within search results
• Ability to track documents submission status and quickly identify and filter out documents which have been approved by the health authorities
• 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
• Automatic ordering of search results based on relevancy
• Export of search results

Unlock and explore the true value of your regulatory dossiers in a safe and secure, web-based eCTD submission management tool, from any region and access them in any location.

Book a demo today and see why pharmaceutical companies around the world are using Dossplorer™ to unlock the true value of their informational assets!

At Celegence, under the leadership of Sonia Veluchamy, we seamlessly blend operational, strategic, and scientific prowess with cutting-edge technology. This fusion enables us to guide our pharmaceutical, medical device, and IVD clients toward regulatory compliance with unparalleled efficiency, both in terms of time and cost. For more information, contact us online!