Passwork
Passwork is a self-hosted corporate password manager built for organizations that take security seriously. Designed and headquartered in Barcelona, Spain, Passwork meets GDPR, NIS2, ENS, and other European regulatory standards by default.
Every password and credential lives exclusively on your own server. A double-layer AES-256 encryption model — applied on both the server and client sides — combined with zero-knowledge architecture ensures your data never leaves your infrastructure. System administrators retain full, uninterrupted control.
Passwork holds ISO/IEC 27001 certification. Enterprises rely on it for secure password sharing, privileged access management, and centralized credential governance — all without exposing sensitive data to third-party systems.
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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
For more information, visit our website.
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LICENSALE
Introducing a comprehensive global regulatory affairs platform, featuring registration management tools and expert support from regulatory professionals worldwide. This system is essential for initiating, renewing, modifying, or transferring market access approvals for your medical devices or IVDs. With LICENSALE®'s user-friendly interface and real-time data capabilities, you gain access to complete project management tools, infographic analytics, a seamless collaboration space, future market access strategies, and detailed reporting features. This empowers you to oversee your global medtech registration processes effectively. Regulatory specialists from Arazy Group meticulously examine your compliance documents, providing guidance in the preparation and submission of your applications, and they liaise with authorities until you secure the necessary marketing approvals. Furthermore, LICENSALE® encompasses specific submission and compliance requirements tailored to your product across over 140 countries, with dedicated regulatory experts available to assist in navigating each market's unique challenges. By leveraging this system, you can streamline your regulatory processes and enhance your overall market entry strategy.
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PhlexRIM
PhlexRIM is set to significantly enhance compliance by providing real-time access to global registration data in a highly efficient manner. The latest version, PhlexRIM 2.0, features a collection of pre-configured automation assistants, known as “bots,” along with built-in regulatory scenarios that adhere to industry best practices. With an easy-to-use drag-and-drop design interface, regulatory teams can streamline their business operations without needing programming skills or assistance from IT departments. Furthermore, it allows for effective management of the pharmaceutical product registration lifecycle. Users can access detailed status updates and take advantage of the alert management system integrated into all workflows. Reporting capabilities are also robust, enabling the use of standard reports or the creation of custom reports tailored to specific needs. Additionally, the platform facilitates the creation and assignment of regulatory tasks within various levels of the organization, including management, departments, headquarters, and affiliates, ensuring cohesive collaboration across teams.
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