A Regulatory Information Management (RIM) system is a comprehensive solution designed to manage the regulatory data, documents, and processes needed to bring life science products to market. By centralizing all regulatory information and automating submission workflows, RIM helps organizations maintain compliance, improve operational efficiency, and uphold data integrity across the product lifecycle.
Modern life science organizations face growing regulatory complexity and pressure to accelerate time-to-market. However, relying on spreadsheets or disconnected tools to manage registrations, submissions, and health authority interactions introduces major risks – from data silos and version errors to missed deadlines and compliance gaps.
Maintain adherence to ever-changing regulations with centralized records and built-in audit trails.
Automate repetitive regulatory tasks to eliminate data entry mistakes and free up your team for higher-value work.
Centralize all regulatory information – from dossiers to health authority correspondence – to ensure everyone works from the same up-to-date data, eliminating silos.
Ensure accuracy, consistency, and traceability of information with controlled workflows and audit trails.
Streamline submission planning, tracking, and approvals to minimize regulatory delays and accelerate market entry.
A cloud-first platform that streamlines global regulatory processes with seamless integration across departments and built-in regulatory intelligence to keep you ahead of changing requirements.
A trusted provider known for eCTD submission management and readiness for new standards like IDMP/SPOR, offering robust validation tools to ensure every dossier meets current regulatory requirements.
A unified platform that integrates RIM with other regulated content (such as quality and clinical data) on a single system, enabling a holistic approach to managing all regulated information.
Pre-implementation analysis and consulting to align the solution with your business and regulatory goals;
Full implementation and configuration tailored to your processes and compliance needs;
Integration with existing systems, including secure data migration, to unify information with minimal disruption;
Customized user training to ensure smooth adoption and confident daily use;
Comprehensive system validation in line with industry regulations and best practices;
Ongoing support to keep your RIM system running smoothly.
eLife Sciences is a team of experts with unique experience in compliance, validation and quality assurance (QA). We provide services to companies in regulated industries with a special focus on life science.
