Ennov RIM

Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc.

Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning.