DXC's Regulatory Information Management Platform is a comprehensive solution designed to streamline and automate regulatory affairs processes for life sciences companies. By integrating compliance components into a unified platform, it enables efficient management of regulatory content, data, and workflows, thereby accelerating innovation and reducing time-to-market for new therapies, devices, and medicines.
Key Features and Functionality:
- Unified Platform: Securely integrates all compliance components, allowing for seamless management of regulatory affairs content, data, and workflows.
- Total Regulatory Solution Suite: Facilitates simultaneous publishing and submission of new drug applications across multiple markets, adhering to various regulatory formats through a single user interface.
- FirstDoc™: Supports research and development , Quality and Manufacturing , and Quality Management System with intuitive navigation, task management, and collaboration tools.
- Tracker: Provides managed RIM capabilities to plan and track drug approvals, maintain compliance, and streamline submission and market authorization activities.
- ToolBox: Offers tools to develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations, with editions tailored for legal, pharma, professional, and standard operations.
- Writer: Enhances productivity and reliability by enabling the creation of regulatory documents using available templates.
Primary Value and User Benefits:
The DXC RIM Platform addresses the complexities of regulatory processes in the life sciences sector by providing a holistic, automated solution. It enhances business agility and operational efficiency, enabling companies to focus on patient-centric innovations. With a track record of 70,000 regulatory submissions without refusals and management of 15,000 pharmaceutical products, the platform ensures compliance and accelerates the delivery of life-saving treatments to market.