Maintains an authoritative, “single source of truth” of product and approved regulatory data
Improves decision making by providing a global view of potential delays and resource conflicts
Maintains complete and accurate registration history with version control
Manages change requests, variations and regulatory interactions
Facilitates consistent regulatory planning and submissions tracking
Tracks all supporting documents required for eCTD, xEVMPD and dossier submissions
Complies with major regulations such as xEVMPD and UDI
Provides seamless integration with 3rd party systems
Regulatory affairs (RA) involves more than managing submissions and license applications. In reality, RA is focused on the tracking and management of the entire regulatory process to ensure that all products are developed, manufactured, licensed and supplied in accordance with the product license, approved manufacturing specifications and global regulations. All of this while optimising the use of scarce resources. Activities include Clinical Trial Authorization (CTA) and Market Authorization (MA) submissions, as well as variation management, questions, obligations and commitment handling.
For many pharmaceutical companies, maintaining and sharing accurate and up-to-date information on their products is a significant challenge, often resulting in a major disconnect between internal departments such as manufacturing, pharmacovigilance and quality. The disconnect found in outsourced or offshored manufacturing of products can be especially difficult, often resulting in significant compliance issues that can lead to administrative sanctions or worse batch recalls and ultimately withdrawal of the product.
Given all of these challenges, it is essential to have a central regulatory information management system that acts as a single source of truth of accurately tracks all regulatory activity.
Register™ - The Market-Leading Regulatory Information Management System (RIMS)
Used by many of the top global pharmaceutical companies, Register™ is the market-leading solution for managing products and tracking global registrations across the entire product lifecycle. Register™ ensures that organizations have a single, integrated solution that automates and establishes full control of all regulatory affairs activities globally.
Track and Monitor All Registration Data
Register™ captures and stores detailed product information and allows authorized users to track and monitor the country-specific and global registration data on a drug and/or medical device product. Compliant with the XEVMPD and UDI specifications, Register™ allows you to maintain accurate product approval data including approved manufacturing specifications for every region while managing any specific product obligations and commitments necessary to maintain the product license.
Manage all Regulatory Submission Activity and Resources
Eliminating the need for time-consuming manual tracking, the regulatory planning module enables organizations to manage the numerous activities and resources associated with global regulatory submissions automating 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 xEVMPD, 21 CFR 11, UDI and ISO IDMP.