FDA Tracker by Leucine 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.

EXTEDOpulse is a comprehensive Regulatory Information Management System (RIMS designed to streamline the entire lifecycle of pharmaceutical product development. It integrates various management hubs—Registration, Document, Quality, Submission, and Safety—into a unified platform, enhancing productivity and ensuring effortless compliance with evolving regulatory requirements. By leveraging advanced technologies like artificial intelligence, EXTEDOpulse offers flexibility and continuous process improvement, addressing the complexities of the life sciences industry. Key Features and Functionality: - Registration Management Hub: Centralizes and manages product registration data, facilitating efficient tracking and compliance. - Document Management Hub: Organizes and controls regulatory documents, ensuring version control and accessibility. - Quality Management Hub: Oversees quality processes, supporting adherence to industry standards and regulations. - Submission Management Hub: Streamlines the preparation, publishing, and validation of regulatory submissions. - Safety Management Hub: Monitors and manages pharmacovigilance activities, ensuring patient safety and regulatory compliance. Primary Value and User Solutions: EXTEDOpulse addresses the challenges of managing complex regulatory processes in the life sciences sector. By providing an integrated platform, it enhances collaboration across departments, reduces errors through consistent data usage, and adapts to changing regulatory landscapes. This leads to increased efficiency, improved compliance, and a more streamlined approach to pharmaceutical product development.

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.

RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.