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Amplexor Life Sciences Suite

Manage enterprise regulated content and processes.

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Overview

The Amplexor Life Sciences Suite (now part of Acolad) is a holistic platform that includes modules for regulatory information management (RIM), submission management, and product data management (IDMP). It emphasizes a 'single source of truth' and data reusability across different processes.

✨ Key Features

  • Product Data Management (ProductExpert for IDMP)
  • Regulatory Information Management
  • Submission Management (SubmissionExpert)
  • Dossier Compilation and Publishing
  • Health Authority Interaction Tracking

🎯 Key Differentiators

  • Holistic platform with integrated submission management
  • Emphasis on referencing data instead of copying to avoid redundancy
  • Strong capabilities in structured data management for IDMP

Unique Value: Provides an integral, data-referencing approach to RIM that reduces data redundancy and ensures a single source of truth for regulatory information.

🎯 Use Cases (4)

Global regulatory compliance End-to-end submission management IDMP readiness and data management Centralizing regulated content

✅ Best For

  • Integrated RIM and submission management
  • Structured data management for IDMP
  • Single source of truth for regulatory content

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies needing a very simple, out-of-the-box tool
  • Organizations outside the life sciences industry

🏆 Alternatives

Veeva Vault RIM ArisGlobal LifeSphere RIM Ennov RIM

Focuses on a 'referencing instead of copying' model, which can lead to better data consistency compared to systems that require data to be moved between modules.

💻 Platforms

Web API

🔌 Integrations

Documentum SharePoint API

🛟 Support Options

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

🔒 Compliance & Security

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

💰 Pricing

Contact for pricing
Visit Amplexor Life Sciences Suite Website →