EXTEDOPulse Reviews & Product Details

RegDesk is the next generation RIMS software with AI technology built exclusively for medical device and diagnostic companies. It is a one stop solution for regulatory teams.

IQVIA RIM Smart is a comprehensive Regulatory Information Management (RIM solution designed to streamline and enhance regulatory processes for life sciences organizations. It offers a unified platform that integrates various regulatory functions, enabling efficient management of product registrations, submissions, and compliance activities. Key Features and Functionality: - Centralized Regulatory Data Management: Provides a single source of truth for all regulatory information, ensuring data consistency and accuracy across the organization. - Submission Planning and Tracking: Facilitates the planning, preparation, and tracking of regulatory submissions, improving efficiency and reducing time to market. - Compliance Monitoring: Automates compliance checks and monitors regulatory requirements to ensure adherence to global standards. - Workflow Automation: Streamlines regulatory workflows through automation, reducing manual efforts and minimizing errors. - Reporting and Analytics: Offers robust reporting tools and analytics to provide insights into regulatory activities and support informed decision-making. Primary Value and User Benefits: IQVIA RIM Smart addresses the complexities of regulatory management by providing a centralized and automated solution that enhances efficiency, ensures compliance, and accelerates time to market for life sciences products. By integrating various regulatory functions into a single platform, it reduces manual efforts, minimizes errors, and provides real-time visibility into regulatory activities, enabling organizations to make informed decisions and maintain a competitive edge in the industry.

FDA Tracker by Leucine is an AI-powered platform that helps pharmaceutical and life sciences companies stay ahead of regulatory risks. With real-time insights into FDA inspection trends, 483 observations, and warning letters, FDA Tracker empowers teams to benchmark performance, uncover hidden risks, and proactively close compliance gaps—before the regulator comes knocking. Key Features Real-Time Inspection Data: Access the latest FDA inspections, 483s, and warning letters across facilities and regions. Company & Site-Level Insights: Drill down into specific companies or sites to benchmark against industry peers. AI-Powered Risk Signals: Spot emerging compliance risks and common failure patterns using smart analytics. Search & Filter with Precision: Find exactly what you need—by product type, region, observation code, and more. Compliance Heatmaps & Dashboards: Visualize performance trends and identify red flags in seconds. Exportable Reports: Create shareable reports for internal audits, board reviews, or inspection readiness plans. Business Impact Proactively Close Compliance Gaps with early visibility into regulatory trends Benchmark Performance against industry peers and FDA expectations Enhance Audit Readiness by focusing on real-world inspection patterns Drive Smarter Quality Decisions with data-backed risk intelligence

Essenvia is a MedTech RIM Platform to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. The Platform makes the lives of MedTech Regulatory Teams easier by supporting Global Registrations, Submissions, Change Assessment, and Regulatory Intelligence.

Validfor is a digital validation lifecycle management platform that modernizes how regulated organizations manage their computerized system validations. Designed for the life sciences, pharmaceutical, and medical device industries, Validfor centralizes all validation activities in one secure and compliant environment. By replacing traditional manual validation with a digital, data-driven approach, Validfor enables teams to plan, execute, and track validation processes with real-time visibility and accuracy. The platform includes built-in templates, electronic approvals, and full traceability to ensure regulatory compliance and consistent documentation quality. Whether you’re managing a single system or an enterprise-wide validation program, Validfor helps your organization stay audit-ready, improve collaboration, and maintain complete data integrity while saving time and reducing compliance risk.