RegDesk
5.0 out of 5 stars
(4 Ratings)
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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Freya
Freya is an AI-powered chatbot designed to streamline the process of navigating complex global regulatory frameworks. It enables users to ask direct questions and receive prompt, accurate, and verified answers based on a comprehensive database of over 40,000 regulations across 150+ markets. Freya offers real-time access to regulatory updates, translations, and document summaries, making it easier for regulatory affairs teams to manage compliance. The platform is powered by over a decade of regulatory intelligence and integrates seamlessly with your existing systems, providing actionable insights and helping companies save time and reduce compliance risks.
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SAI360
The most powerful, agile approach to risk management. The decisions you make today can help mitigate the risks you may encounter tomorrow. SAI360 is cloud-first software and modern ethics and compliance learning content designed to help your organization effectively navigate risk with a flexible, agile approach. Intelligent solutions, global expertise all in one award-winning platform.
Solution configurability, extensible data model with configurable UI/forms, fields, relationships to extend solutions. Process modeling, easily modify or create new processes to automate and streamline risk, compliance, and audit activities. Data visualization and analysis, many out of the box and easy to configure dashboards to visualize and analyze data. Learning and best practice content – preloaded frameworks, control libraries, and regulatory content along with values-based ethics and compliance learning content. System integration – Integration framework with APIs and other protocols.
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RegAffairs AI
RegAffairs AI is an AI research assistant for regulatory affairs, compliance and product stewardship teams. You ask a regulatory question in plain language and an agent researches it across 1,046 official regulation databases from more than 340 regulators in 43 jurisdictions, covering chemicals, pharma, food, cosmetics, pesticides, biocides, fashion and EHS. The answer comes back in minutes with every claim cited to the exact regulation, annex entry or judgment paragraph, and each citation opens the stored source document. The research trail, every search and document the agent read, is shown on the page, so the work can be checked and handed to legal. Answers come only from the indexed official text; where the record is silent, the answer says so. Typical questions: is a substance still listed or restricted, what changed after the last amendment, how two markets differ, and who has to notify by when. Questions are never used for training.
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