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Regulatory
Information
Management (RIM)

for Pharma Biotech

A modular platform for Pharma & Biotech to streamline product registration, manage regulatory impact assessments, automate publishing activities, manage global submissions, and ensure regulatory compliance efficiently.

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Countries Supported

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Submissions Managed

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Part 11 Compliant

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Real-Time Tracking

Why Choose Visu RIM?

End-to-end regulatory lifecycle management from planning to tracking to compliance.

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Global Visibility

Gain a single source of truth for all product registrations and market authorizations worldwide. Track
status in real-time.

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Submission Planning

Efficiently plan and track regulatory activities. Manage submission content plans and timelines to ensure country specific compliance is met.

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Compliance Tracking

With built in regulatory requirements for over 140 markets, ensure market compliance at all times and see gaps quickly.

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XEVMPD & IDMP

Built-in support for data standards including XEVMPD and IDMP, ensuring your data is structured for future compliance.

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Seamless Integration

Leverage built in Document Management module or connect to external EDMS, Submission tools, and Labeling systems for a connected regulatory ecosystem.

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Advanced Analytics

Dashboard analytics provide insights into submission volume, approval times, and workload distribution across regions.

Key Capabilities

Empowering Regulatory Affairs teams with digital automation.

Product Registration Management

Manage the entire lifecycle of product details, certificates, and authorizations across all global markets.

Submission Management

Plan, track, and manage all submission types (MAA, NDA, Variations) with detailed workflow automation.

Health Authority Interactions

Centralize all HA correspondence, questions (RFI), and commitments to ensure timely responses.

Regulatory Intelligence

With 140+ countries regulatory intelligence built in and updated weekly, subscribe to country and function specific alerts.

Platform Interface

Check the intuitive interface of Visu RIM, designed for Pharma and Biotech. (Click images to enlarge)

Ready to Transform Your Regulatory Operations?

Move away from spreadsheets. Adopt a compliant, data-driven RIM solution designed for modern Biopharma.

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BioPharma_Regulatory-Information-Management

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