Scigeniq RMS is a comprehensive, automated system that manages every aspect of the regulatory process, from initial planning to final submission and archiving, all organized around best practices to meet global regulatory requirements efficiently.
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Scigeniq RMS gives life sciences companies a complete system to manage the entire regulatory submission process. It handles everything from planning and tracking to final submission and archiving—all while meeting regulatory requirements and best practices. No more siloed data, missed deadlines, or manual processes.
Streamlines document tracking, submissions, and approvals and automates processes for reviews, approvals, renewals, and variation submissions.
Track, process, and manage all aspects of the submission process across jurisdictions.
Automate reviews, approvals, renewals, and variation submissions with built-in workflows.
Real-time dashboards show status, readiness, and regulatory milestones.
Ensure consistency across submissions by providing a single source of truth for regulatory dossiers, correspondence, and historical filings.
Metadata tagging for fast document retrieval.
Collaboration tools for regulatory, clinical, and quality teams.
Reduce submission preparation time and eliminates errors that can cause delays in approvals. The result is more timely and complete submissions, accelerating product introductions.
Electronic submission (eCTD) support with audit trails.
Automated compliance checks and submission tracking across regions.
Integrated “Plan & Track” tool monitors progress vs. plans and pending actions.
Automate the regulatory submission process across multiple jurisdictions, reduce time-to-market, and ensure compliance for your life sciences products.
Monitor the status of submissions and registrations in real time, with visibility across global regions.
Automate the routing, review, and approval of documents to speed up internal processes and reduce human error.
Store all regulatory dossiers, correspondence, marketing authorizations, and historical filings in a single, searchable location.
Enable real-time collaboration between regulatory, quality, and clinical teams to ensure alignment and consistency.
Manage submission calendars, track progress vs. plans, and identify pending deliverables or actions.
Ensure every step aligns with regulatory standards through embedded controls and validation checks.
Use tags and filters to locate specific documents or dossiers quickly and accurately.
Gain visibility into submission readiness, document status, and key regulatory milestones with dynamic dashboards.
Discover how Scigeniq RMS can simplify your processes and accelerate your path to market.
