RegDesk
RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies.
• Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes
• Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time
• Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required
• Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners
• Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards
• Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds
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Definitive Healthcare
Gain access to top-tier information and insights regarding hospitals, medical professionals, and various healthcare providers, with daily updates ensuring accuracy. Our mission is to assist businesses throughout the healthcare landscape in expanding their operations and forging innovative pathways to success in the market. There are numerous reasons we have maintained our status as a frontrunner in healthcare commercial intelligence for over a decade. Driven by cutting-edge data science and artificial intelligence, we provide comprehensive intelligence tailored to all your business requirements. Healthcare commercial intelligence effectively clarifies the intricate network of data related to delivery systems, healthcare providers, insurers, patients, government entities, and more, allowing you to pinpoint the most suitable individuals, opportunities, and organizations for your offerings. Navigating the healthcare market with a new product can be challenging, as vital insights are frequently hidden within various fragmented data systems, complicating the quest for cohesive understanding. This is where healthcare commercial intelligence (HCI) steps in, representing a groundbreaking category of software that simplifies the complex data landscape surrounding healthcare delivery. By leveraging HCI, businesses can not only streamline their access to vital information but also enhance their strategic decision-making processes.
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Ennov Regulatory Suite
Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.
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Kalypso Accel for RIM
Kalypso offers a budget-friendly solution for life sciences organizations looking to implement a Regulatory Information Management (RIM) system, known as Accel for RIM. This platform facilitates an integrated approach to effectively oversee and monitor product registrations while enhancing the accuracy of submissions and managing global Unique Device Identification (UDI) information, thereby streamlining product distribution. It also merges compliance and quality data from multiple enterprise systems into a comprehensive source of truth for product registrations and tracking, which expedites regulatory submissions. Utilizing modern APIs, it aggregates product data along with necessary regulatory documentation and submission packages. The system is pre-configured for swift deployment and is built on a validated software framework, grounded in the best practices and successful implementations within the industry. By adopting this solution, companies can expect not only efficiency but also a significant reduction in time spent on regulatory tasks.
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