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Modern RIM technology that drives business value and brings cross-functional efficiency gains to all teams and departments (RA, QA, R&D, PMO).
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Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs and RFIs.
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Powerful technology to support Registrations, Submissions, and Change Assessement, while increasing productivity and allowing regulatory specialists focus on high-value activities.
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Peace of mind when dealing with ever-changing regulations for different regions and strict deadlines. with a 100% submission acceptance rate guarantee.
Module
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Features include:
Manage product registration lifecycle by country
Central repository for all registration docs linked to product master data
Dashboard with ability to track global registration status
Alerts and notifications
Integration to ERP/PLM for data and document sync
Module
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Features include:
Extensive templates library compliant with all regulations and countries
Reusable content automation across submissions
PLM/eQMS integration to automate submissions
FDA eSTAR collaborative authoring (unique and patented technology)
Instantly generate final submission files with 1-Click
Module
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Features include:
Automate regulatory change assessment
Determine impact of change (significant or insignificant)
Automate creation of Letter to file / Memo to file
Project management across changes from initial assessment to closure
