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 Aris Global products, Register is available on premise or on demand. The Aris Global 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.
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.
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: