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
For more information, visit our website.
Learn more
Maintenance Care is a cloud-based, facilities maintenance management solution that helps organizations of all sizes manage work orders, assets, preventive maintenance tasks and more from any device. Maintenance Care includes a mobile CMMS to make task completion and tracking easier on-site or on the go.
Maintenance Care’s CMMS (computerized maintenance management system) includes a host of powerful but easy-to-use features, including asset tracking, parts and inventory management, dashboards, reporting, document storage, third-party integrations and more. Preventive scheduling functionality helps users handle in-progress tasks and plan for bigger projects to address what work needs to be done and when.
Additionally, document storage capabilities allow users to attach various forms, such as MSDS, training PDFs and safety documentation to tasks. The CMMS includes an asset management module that provides details related to purchase, manufacturing, technical specifications, warranty expiration and repair history on equipment.
All paid plans include unlimited users — this means no extra cost per seat. Cost-effective paid plans include more robust features anyone can quickly learn and start using.
Learn more
Labrynth AI
Labrynth serves as an AI-driven regulatory intelligence platform tailored for organizations operating within intricate and heavily regulated sectors.
Teams navigating regulatory frameworks often contend with a multitude of disparate rules, agency guidelines, technical specifications, internal protocols, earlier submissions, supporting documentation, and historical review data. While general AI solutions might provide responses, they frequently fall short in terms of source traceability, auditability, and the necessary context for workflows. Labrynth addresses this execution gap effectively.
The platform not only maps obligations but also verifies documents and evidence, uncovers deficiencies, and assists teams in producing outputs that are cited, ready for review, and compliant with audit standards. Each piece of advice is linked back to relevant source materials, regulatory requirements, historical reviews, and corroborating evidence, empowering experts to accelerate their processes without sacrificing oversight. Additionally, Labrynth enhances collaboration among team members, ensuring that everyone is aligned and informed throughout the regulatory journey.
Learn more
RegDocs Connect
RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.
Learn more
