RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market.
Our capabilities are as follows:
• AI Application Builder
• Regulatory Intelligence
• Change Assessment
• Standards Management
• Country-Specific Templates
• Distributor Collaboration
• AI Document Management
• Tracking & Reporting
• Alerts and Notification
• Product Management
• Claims Management
• EUDAMED
For more information, visit our website.
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Kivo
Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc.
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