RIMExpert Description
RIMExpert™ effectively streamlines regulatory planning, tracking, and data management by overseeing global rollout strategies and automating the preparation of regulatory applications, activities, and medicinal products. By minimizing data entry requirements, RIMExpert™ enhances data integrity while boosting global oversight and control. The platform standardizes processes related to regulatory planning, tracking, and registration management, which in turn fosters improved collaboration between headquarters and their affiliates. It also establishes a centralized workspace for all registration-related activities. This single access point consolidates all inquiries, commitments, correspondence, and authorizations for each application, thereby synchronizing efforts to achieve optimal efficiency in enterprise regulatory resources. RIMExpert™ enables precise control over registration activities throughout a product's lifecycle, ensuring that timelines and the status of commitments and agency inquiries are continuously monitored. Additionally, it features interactive dashboards that provide a comprehensive overview of regulatory activities and registrations, empowering teams to make informed decisions and take timely actions. In this way, RIMExpert™ not only enhances regulatory compliance but also drives organizational effectiveness.
RIMExpert Alternatives
Adaptive Compliance Engine (ACE)
Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant.
Our one-stop software includes:
-Office 365 Integration
-Inspection Management
-Document Management
-Risk Management
-Product Lifecycle Management
-Learning Management
-Audit Management
-Quality Events
-Paperless Validation
-Electronic Signatures (21 CFR Part 11 Compliant)
-Endless Workflow Configurations
-And so much more!
Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform.
ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.
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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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ViSU
ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.
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Integrations
No Integrations at this time
Company Details
Company:
AMPLEXOR
Year Founded:
1987
Headquarters:
Luxembourg
Website:
www.amplexor.com/en/life-sciences-suite/rim/regulatory-planning-tracking.html
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Product Details
Platforms
Web-Based
Types of Training
Training Docs
Webinars
In Person
Training Videos
Customer Support
Business Hours
Online Support
RIMExpert Features and Options
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