The Market-Leading Regulatory Information Management System (RIMS)
Regulatory affairs are not simply about document submissions; they are an elaborate set of processes involving end-to-end management, tracking and maintaining regulatory submissions. These activities include the initial submission as well as variations, questions, obligations and commitment handling.
Used by five of the top ten pharmaceutical companies, Register is a market-leading solution for managing products and tracking global registrations across product lifecycles. Register ensures that organizations have a single, integrated regulatory submissions management system that can automate and establish full control on all regulatory affairs activities across the globe.
As with all ArisGlobal products, Register is available on premise or on demand. The ArisGlobal on demand platform is called agOnDemand. For over four years, agOnDemand has been providing best-in-class Software-as-a-Service (SaaS) to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.
Achieving and maintaining regulatory compliance
Register captures and stores detailed product information and allows authorized users to track and monitor the drug and/or medical device product and the country and company specific registration data about such a product at the global and/or local level. The planning module in Register enables organizations to manage the numerous activities and resources associated with global regulatory submissions.
Maintains authoritative database of all products worldwide
Tracks all supporting documents required for eCTD, EVMPD and Dossier submissions
Supports national, centralized, and mutual recognition submission procedures
Manages variations/supplements, tracking changes in formulations, packaging, indications, manufacturing and composition
Maintains complete registration history with version control
Seamlessly links to Documentum, SharePoint, Oracle databases and SAP system
Tracks licensing agreements and cooperative ventures with other organizations (in-license and out-license agreements)
Automates question-and-answer processing facility that enables the users to route regulatory or other questions to responsible departments
Sends alerts and instant notifications in real-time via email, SMS, or online messenger
Provides flexible ad hoc query & reporting
Has an intuitive user interface for enhanced user experience
Mitigating risk through accurate global view of the enterprise
Eliminating the need for time-consuming manual processes, Register automates the definition, distribution and reporting of project plans at the global and local/regional level. As a result, Register improves visibility across the organization, giving users and management a global view of potential delays and resource conflicts, enabling faster, informed decision making at lower cost while ensuring compliance with various regulations such as EVMPD, 21 CFR 11, and 501K. Other benefits include:
Gives users complete control over the entire global product registration process
Accelerates the product approval process, reducing time to market
Adapts to suit your organization’s needs making your organization very agile, responsive and responsive to change
Complies with major regulations such as EVMPD, 21CFR11, and 501K
Mitigates compliance risk by providing an authoritative and single source of approved regulatory data across the organization
Facilitates tracking and control of the global submission process in accordance with local regulations
Keeps your product information updated for each territory where it is registered and marketed
Contributes to effective and intelligent decision making through comprehensive reporting and alert notifications
Enables achieving and maintaining compliance with manufacturing by providing access to verified and approved product approval information
Ensures consistent planning and submissions process through the use of planning templates
Low-cost, rapid implementation ensures maximum return on investment