Calyx RIM

Manage and track regulatory information with confidence.

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Overview

Calyx RIM is a comprehensive and scalable system designed to manage the entire regulatory lifecycle. It provides a centralized repository for all regulatory information, helping life sciences organizations to maintain compliance, improve efficiency, and ensure data quality across their global portfolio.

✨ Key Features

  • Centralized Global Product Information
  • Submission and Registration Tracking
  • Health Authority Correspondence
  • Commitment Management
  • Standardized Reporting and Analytics

🎯 Key Differentiators

  • Proven and established system with a long history in the market
  • Deep integration capabilities with the Calyx clinical suite (CTMS, EDC)
  • Focus on providing a reliable, scalable enterprise solution

Unique Value: Offers a proven, reliable, and scalable RIM system that provides a single source of truth for regulatory information across the product lifecycle.

🎯 Use Cases (4)

Global product registration management Tracking clinical trial applications Managing post-market surveillance activities Centralizing regulatory data for portfolio oversight

✅ Best For

  • Enterprise-wide regulatory information management
  • Lifecycle tracking for pharmaceuticals and medical devices
  • Integration with clinical trial management systems

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies needing a primary submission publishing tool
  • Organizations outside of the life sciences industry

🏆 Alternatives

Veeva Vault RIM IQVIA RIM Smart ArisGlobal LifeSphere RIM

Provides the benefit of tight integration with a leading clinical trial technology suite, offering a more unified approach for companies managing both clinical and regulatory data.

💻 Platforms

Web API

🔌 Integrations

Calyx CTMS Calyx EDC API

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (Varies tier)

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ GxP ✓ ISO 9001

💰 Pricing

Contact for pricing
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