FDA Tracker by Leucine is not the only option for Regulatory Information Management (RIM) Systems. Explore other competing options and alternatives. Other important factors to consider when researching alternatives to FDA Tracker by Leucine include ease of use and reliability. The best overall FDA Tracker by Leucine alternative is MasterControl Quality Management System. Other similar apps like FDA Tracker by Leucine are Clinical Research Suite, Kivo, Rimsys, and Veeva Vault RIM. FDA Tracker by Leucine alternatives can be found in Regulatory Information Management (RIM) Systems but may also be in Quality Management Systems (QMS) or Clinical Trial Management Systems.
MasterControl Inc. produces QMS software solutions which enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle.
Research Manager supports researchers and organisations in preparing, executing and administering (clinical) research data. Our expertise is the collection, validation and enrichment of data. With Research Manager, we offer a research platform that allows researchers to have all functionalities and information in one place and to share it with each other. The platform facilitates researchers who want to be prepared for a future where the patient, access to data, and sharing data are key.
Kivo makes simple and affordable document management systems including RIM, eTMF, and QMS. A single license grants access to all our solutions, so you can supercharge cross-functional collaboration without breaking the bank. Fully validated, Part 11 and SOC 2 compliant, Kivo is designed forGxP.
The Vault RIM Suite provides fully integrated regulatory information management (RIM) capabilities on a single cloud-based platform including submission document management, product registration management, health authority correspondence and commitments, submission archiving, and comes with fully integrated IDMP capabilities.
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.