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Montrium Adds Regulatory Submission Tracking & Planning with the Release of Regulatory Navigator

Montrium Adds Regulatory Submission Tracking & Planning with the Release of Regulatory Navigator

The Regulatory Navigator is an Integrated Regulatory Information Management Tool for RegDocs Connect

Montrium, regulatory compliance specialists, and enterprise content management software providers, today, announced the commercial release of the Regulatory Navigator, an interactive intelligence dashboard integrated into RegDocs Connect, their Regulatory EDMS. Equipped with powerful business intelligence and intuitive regulatory document management, pharmaceutical organizations now have the tools to significantly improve the quality of their content while speeding up the submission timeline.

As the FDA deadline for eCTD submissions approaches and the complexity of drug development continues to increase, life sciences companies need sophisticated and easy to use tools that help them produce submission-ready, quality content in a timely manner. By combining document creation, dossier management, product registrations, and health authority interactions in one place, life sciences companies can increase the speed, efficiency, agility and compliance of their regulatory teams.

"Traditionally, Life Sciences companies have struggled with disconnected regulatory landscape, where information is managed in several systems, and in multiple regions." said Paul Fenton, President & CEO at Montrium. "The Regulatory Navigator, paired with RegDocs Connect, marries essential RIM functionality with powerful document authoring and management, allowing regulatory teams to create, plan and track the entire regulatory timeline, in one place.

"Much like Montrium's other Navigator tools, the Regulatory Navigator provides visual indicators that provide clarity and transparency over the completeness of your submissions, ensuring that everything you send for publishing is submission-ready. Regulatory teams can now quickly identify all available, expected, in-process or missing submission documents by products, regions, countries, applications or sequences and begin creating regulatory activities directly in the navigator.

The Regulatory Navigator is now available globally as part of Montrium's RegDocs Connect product. To learn more about Navigator Tools or to schedule a demo of the Regulatory Navigator, please register for our live demonstration where we will be giving attendees an exclusive walkthrough of the Regulatory Navigator.

Additional Information

To learn more about the Montrium Connect platform and its suite of regulated content management applications, including RegDocs connect and eTMF Connect, visit montrium.com/connect.

To learn more about Montrium's latest release, please visit: https://www.montrium.com/regdocs-connect/navigator

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About Montrium

Montrium is a global leader in cloud-based document and quality management solutions (QMS) and GxP consulting services for the life sciences. Operating in the life sciences for over ten years, Montrium has been successfully helping organizations implement and maintain technology to improve their business processes and increase compliance. Montrium currently serves over 7500 satisfied users in over 20 countries. For more information on the products and services Montrium provides, please visit their website: www.montrium.com


Oliver Pearce

Head of Growth, Montrium


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