Is your regulatory expertise being allocated to rote data management and at the cost of strategic initiatives? Based on industry statistics, life sciences companies today spend as much as 70% of regulatory efforts on repetitive manual activities maintaining their global registration compliance. Is this precious time taking away from your ability to focus on strategic initiatives? Could this time be better directed towards anticipating, delivering, and repurposing regulatory information to meet corporate goals?

Providing access to life-enhancing products requires ensuring the maximum availability of your product portfolios to your patient population. At Instem, we support you in meeting this goal by automating your regulatory processes while ensuring compliance across multiple product types and regions with our Regulatory Information Management (RIM) system, Samarind RMS.

Samarind RMS Dashboard


 

Samarind RMS logo

Your Single Place of Truth™ for Regulatory Information

 

 

Samarind RMS is a fully integrated RIM system, purpose-built to accelerate regulatory operations for the pharmaceutical drugs, veterinary medicines, medical devices, and in vitro diagnostics industries.

Samarind RMS is uniquely positioned to help address the needs of today’s Regulatory Professionals ensuring high efficiency and quality in their work processes. Our customers manage their regulatory information in a single end-to-end RIM system safe in the knowledge that our single-place-of-truth™ approach eliminates data re-entry and ensures repurposing and accuracy of information and workflows across the product lifecycle.

 



Samarind RMS Features

  • Built-in data structures and templates for the secure storage of product, submission, and registration data
  • Global support for regional data capture and exchange requirements including eCTD, UDI, ISO IDMP, VNeeS, NeeS, etc.
  • Support for regulatory interactions and change management through project planning and management tools
  • Activities and deadline tracking with automated notifications, alerts, and dashboards
  • User defined searches and reports to support regulatory impact assessment
  • API architecture for data exchange
  • Dashboards and analytics

 


Key Benefits

  • Improve quality and compliance with global regulations
  • Reduce time to submission and approval
  • Minimize resources spent on verification and remediation
  • Improve efficiency and productivity of global regulatory operations
  • Leverage regulatory data as a corporate asset
  • Enhance strategic decision process
  • Enable reporting on key performance metrics
  • Drive cost-functional change management
  • Realize true data exchange with MDM, ERP, PLM, and EDMS

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Samarind RMS provides the most efficient, practical and cost-effective way to
manage all regulatory information in one place.

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