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Montrium Regulatory Navigator

Take control of your regulatory documents and submissions.

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Overview

Montrium's Regulatory Navigator is part of their unified content management platform for life sciences. It helps teams manage regulatory information, documents, and submissions in a controlled GxP environment. The system is designed to streamline the creation of submission-ready content and provide a clear line of sight into regulatory activities.

✨ Key Features

  • Centralized document repository
  • Submission content planning
  • Version control and audit trails
  • Configurable workflows for review and approval
  • Based on the DIA RIM Reference Model
  • eCTD binder templates

🎯 Key Differentiators

  • Focus on emerging and mid-sized life sciences companies.
  • Unified platform that also includes eTMF and QMS applications.
  • Pre-configured, best-practice workflows to speed up implementation.

Unique Value: Offers a pre-configured, compliant, and unified platform for managing regulatory documents and submissions, tailored for the needs of emerging life sciences organizations.

🎯 Use Cases (4)

Managing documents intended for regulatory submissions Planning the content for upcoming submissions Collaborating on submission authoring and review Maintaining a compliant repository of regulatory information

✅ Best For

  • Regulated content management for emerging biotech and life sciences companies.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies that require an all-in-one solution with integrated eCTD publishing.

🏆 Alternatives

Veeva Vault Submissions MasterControl Documents OpenText Documentum

Provides a more streamlined and faster-to-implement solution compared to highly complex and customizable enterprise platforms.

💻 Platforms

Web

🔌 Integrations

Montrium eTMF Connect Montrium Quality Connect Microsoft Office

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (All tier)

🔒 Compliance & Security

✓ SOC 2 ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ GxP

💰 Pricing

Contact for pricing
Visit Montrium Regulatory Navigator Website →