Regulatory operations play a vital role in ensuring that organizations can bring safe and effective life-enhancing products to market faster while ensuring compliance with global regulatory requirements.

Driven by scientific and technological innovation, increased globalization, and continuously evolving regulatory requirements; today’s regulatory professionals contend with a high volume of complex data which needs to be managed and exchanged effectively with internal departments and health authorities. Whether it’s managing expanding UDI requirements for medical devices, transitioning from the EU's MDD to MDR, the drive towards the global implementation for ISO IDMP, or meeting the challenges of new innovative Combination Products, organizations require specialized and integrated tools that enable real-time collaboration between regulatory teams.

Regulatory Information Management



 

Your Single Place of Truth™ for Regulatory Information

 

 

Imagine having all your regulatory information in one place. Products, licenses, registrations, suppliers, dossiers, health authority interactions, and regulatory change management workflows all linked together within one system.

Samarind RMS offers all these capabilities and more in a purpose-built, data-driven RIM system that ensures compliance and optimizes regulatory operations.

 



Samarind RMS Features

  • Dashboards and analytics
  • Dynamic regulatory impact assessment tools
  • Project management workflows
  • Built-in event monitoring triggering alerts and notifications
  • Preconfigured dossier and submission templates
  • Integrated EDMS
  • Interfaces with third party systems

 


Key Benefits

  • Improve efficiency and productivity of global regulatory operations
  • Enhance strategic decision making
  • Reduce time to submission and approval
  • Reduce the cost of life-cycle maintenance
  • Drive cross-functional change management
  • Realize true data exchange with MDM, ERP, PLM, and EDMS

RIM Resources

A monthly medical devices blog for today's regulatory professional

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The most efficient, practical and cost-effective way to manage all regulatory information in one place

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Get a better handle on Global UDI compliance in an increasingly complex environment

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A bi-weekly blog for today's
Regulatory Professional

Visit the blog

Leverage technology solutions to improve regulatory operations information management

Watch the webinar