RegDocs Connect

RegDocs Connect is a cloud-based Regulatory Information Management (RIM) platform developed by Montrium, purpose-built for lean regulatory affairs teams in pharmaceutical, biotech, medical device, and CRO organisations. Designed to accelerate submission readiness and improve visibility into regulatory activity, it serves as a centralised command centre for planning, executing, and tracking global regulatory submissions from a single unified environment.

Unlike larger enterprise RIM platforms that require significant resources to implement and configure, RegDocs Connect is specifically engineered for smaller teams looking to scale. It combines submission planning, document management, health authority correspondence tracking, and regulatory intelligence into one connected platform — enabling regulatory professionals to move faster while maintaining data integrity and compliance throughout the submission lifecycle.

Submission Planning and Portfolio Management

• Plan, execute, and track regulatory content development and data in a single RIM interface
• Built-in automation and full support for all major eCTD submission requirements
• Automate the development of submission content plans
• Associate content to multiple submissions simultaneously
• Aligned with eCTD and EDM Reference Model standards
• Enables regulatory affairs teams to accelerate speed to market across the entire product portfolio

Centralised Regulatory Information and Reporting

• Securely store all regulatory data in one unified, cloud-based platform
• Drill down to identify the exact source of delays using the regulatory navigator dashboard
• Take direct action from the dashboard to address holdups and keep teams on track with submission deadlines
• Document import, creation, and collection capabilities
• Aligned to eCTD and EDM reference model
• Interactive dashboards and reporting for real-time visibility into submission status and regulatory activities

Regulatory Document Collaboration and Authoring

• Full document management system to centralise collaboration across the entire organisation
• Supports regulatory affairs teams, central leadership, local affiliates, and internal clinical, safety, and quality teams
• Document template management with Microsoft Word integration
• Review and approval workflows on documents
• Automatic task distribution and notifications to keep contributors aligned
• Designed to modernise the development of submission-ready documents organisation-wide

Health Authority Correspondence and Commitment Management

• Capture and manage different types of health authority correspondence in one location
• Create and delegate commitments arising from health authority interactions
• Track ongoing activity progress to maintain pace with regulatory requirements
• Robust notifications and task creation to put submission interactions on autopilot

Submissions Archive and Author-to-Archive Workflow

• Store previously submitted sequences in a centralised submissions archive
• Navigate through archived documents using the XML backbone of the submission
• Reuse and reference existing submission content in future submissions to improve efficiency

Compliance, Security, and eCTD Publishing Support

• Content organised in accordance with ICH eCTD structure, enabling easy export and portability to existing publishing systems
• Cloud-based platform secured with multiple layers of physical and operational security, encryption, firewalls, and intrusion detection and prevention systems
• Regular security audits, assessments, and recognised compliance certifications
• Supports regulatory compliance by providing real-time submission information, reports, and insights to keep the entire RA team informed

RegDocs Connect is part of the broader Montrium platform, which also includes eTMF Connect and Quality Connect. Montrium supports organisations across pharma, biotech, medical device, non-profit, and CRO sectors, and offers a tried-and-tested implementation methodology designed to reduce burden, speed up timelines, and maintain compliance from day one.