Regulatory operations within the pharmaceutical industry face many challenges when it comes to managing, maintaining, and filing product information with global regulators. These challenges include ensuring compliance with new and existing regulations, overseeing all the forms, data and documents needed for successful submissions, as well as preserving the status of those global licenses all while keeping track of tight deadlines.

Historically, regulatory professionals within the pharmaceutical community have not had access to software solutions designed to meet their specific needs. This resulted in organizations managing and tracking information across multiple spreadsheets and cross-referencing files in document management systems leading to a cumbersome, error-prone, complicated, and expensive process.

Until now, solutions available to regulatory professionals only addressed a small selection of regulatory functions. This resulted in tools that only supported a few industry needs or required large integration and maintenance investments to make them fit for purpose.

Samarind RMS Dashboard


 

Your Single Place of Truth™ for Regulatory Information

 

 

Imagine having all your regulatory information in one place. Products, licenses, registrations, facilities economic operators, documents, and workflows all linked together within one platform. Samarind RMS, a purpose-built pharmaceutical RIM system, is that single place of truth to leverage your regulatory information into streamlined workflows that can provide insight into upcoming activities as well as past knowledge of activities to drive your organization forward.




Samarind RMS Features

  • Management of medicinal product life cycle from planning to post-market support
  • Templates for dossiers, documents, data attributes and change management workflows
  • Project planning and management tools to support regulatory interactions and change management
  • Renewal and deadline tracking with automated notifications, alerts, and dashboards
  • Management of regulatory communications and commitments
  • IDMP compliant processes and workflows

 


Key Benefits

  • Increase market availability of your product portfolio
  • Ensure compliance with evolving regulatory requirements
  • Reduce time to submission
  • Improve confidence in submission data
  • Access to medicinal products, submissions, and licenses in real-time
  • A secure integrated Electronic Document Management System

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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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