10 Small Submissions
No more than 10 Documents per submission
registrations assembly and management for Health Authority approvals - Freyr SPAR is an advanced RIM solution that easily handles multiple products, global markets, and ever-changing Regulatory requirements.
next generation system
for global products and registrations management
Various products, several markets, merged with varied Regulatory requirements, challenge Life Sciences companies to secure and preserve a broad range of information to obtain Health Authority (HA) approvals. The constantly updated regulations, demand for global formats, and upsurge of data requirements question the methods in which Regulatory information is being managed.
A next-gen advanced Regulatory Information Management System (RIMS) - Freyr SPAR (System for Products and Registrations) optimizes the Regulatory submissions process, accelerates time-to-market, helps better process integration, and unifies information at a single location, which is accessible from any part of the world in a single click. With technologically advanced architecture integrated with ever-evolving Regulatory standards, Freyr SPAR maintains information – from tracking product registrations, marketing authorization lifecycles, product data, Regulatory document management, HA interactions to generating reports with a zero-footprint viewer.
functional highlights
end-to-end registration lifecycle management – variations, renewals, commitments and obligations
IDMP ready
ability to integrate with EDMS, eCTD submissions publishing, labeling change tracking, XEVMPD, IDMP, SPL
wizard-based record creation handle multiple products
customizable reports and user-specific dashboards
unified repository for all documents
key features
manage and access metadata with a few easy clicks
highly customizable and a robust report can be configured based on the customers’ requirements
ability to integrate with EDMS, eCTD submissions publishing, labeling change tracking, XEVMPD, IDMP, SPL
application can be accessed using a browser over the web
user interface is very intuitive and easy to understand and navigate
improve navigation with powerful search filters for a specific record
