Consolidate your Regulatory Activities into One Centralized Platform
Essenvia leverages AI to make it easy to manage registrations, submissions, changes, and communication with health authorities, allowing your regulatory specialists to concentrate on high-value activities.
Why Choose the
Essenvia RIM Platform?
Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.
Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.
Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.
All-in-One Platform
AI-powered
Registrations
Management
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Features include:
Manage SKU-level 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
AI-powered
Submissions
Management
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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)
AI-powered
Change
Management
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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
