Celegence unveils next level efficiencies for eCTD compliance with new functionality added to Dossplorer™

Celegence, a global provider of regulatory affairs services and solutions for the life sciences industry has added new functionality to Dossplorer™, its advanced, cloud-based dossier management solution.

Dossplorer™ from Qdossier, a Celegence company enables users to create transparency, consistency, and reusability across regulatory dossiers. New intuitive search functionality has been added to the solution to enable clients to unlock the full potential of regulatory dossiers and provide greater efficiencies for eCTD (electronic common technical documents) compliance.

Pharmaceutical companies can spend huge amounts of time and effort importing product registration dossiers and getting regulatory submissions ready to comply with eCTD, a standard format of submitting regulatory information to the Health Authorities. The powerful new advanced search module in Dossplorer™ helps speed up this process by enabling pharmaceutical companies to find documents and registrations in seconds and filter searches as required. The new functionality also makes it easier to identify and assess where a certain substance or manufacturer has been referenced previously.

Helping pharmaceutical companies document proof of quality, safety, and efficacy of their medicinal products, Dossplorer™ not only enables the transfer of information to the regulators, it also supports other use cases such as regulatory impact assessment and change control procedures, safety enquiries or marketing claims.

Hans van Bruggen, Founder of Qdossier and Chief Scientific Officer at Celegence said: “We understand the pressures that pharmaceutical companies face when it comes to finalising their applications for review by the Health Authorities.

“Enabling right first time eCTD lifecycle and regulatory information management, Dossplorer™ can save pharmaceutical companies valuable time and resources. This new advanced search module is the latest addition to our game-changing solution and enhances yet further our intuitive and easy-to-use dossier management and regulatory submissions solution.”

A significant amount of regulatory information is often trapped digitally in a PDF format. Dossplorer™ helps unlock this information and offers full text indexing and advanced analytical capabilities.

Other benefits of the solution include the ability to access a holistic view across multiple applications to support fast and informed decision making. Users can also view obsolete documents and version history and prevent two versions of the same document being worked on simultaneously.

Qdossier was acquired by Celegence in July 2022, enhancing the organization’s extensive network of regulatory consultants and solutions for the pharmaceutical industry.

ENDS

About Celegence

Celegence helps life sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to regulatory affairs. It supports life science customers in the areas of EU MDR compliance, IVDR compliance, regulatory intelligence, RIMS data management, publishing, regulatory labeling including UDI consulting, and medical writing. It acquired Qdossier in July 2022, experts in right first time eCTD lifecycle and regulatory management. Its advanced, eCTD management solution, Dossplorer™, supports document and dossier lifecycle management for pharmaceutical products.

Celegence's depth of experience and extensive delivery capabilities allows regulatory affairs and quality teams to operate more efficiently, reduce cost, and improve compliance. For more information, visit www.celegence.com or follow Celegence on LinkedIn.            

For further information please contact:

Rachel Hollos

Marketing Director at Celegence

rhollos@celegence.com

Press contact:

Fiona Whyatt

Senior PR manager at ramarketing

fiona.whyatt@ramarketingpr.com