The global veterinary regulatory environment is evolving at a fast and furious pace. Whilst legislative changes are intended to reflect the scientific progress in animal health, regulatory operations continue to face many challenges when it comes to managing, maintaining, and filing product information with regulators. These challenges include ensuring compliance with existing and new regulations such as Regulation (EU) 2019/6 (NVR) in Europe. The regulatory team is charged with overseeing all the forms, data transmission and documents needed for successful submissions, as well as preserving the status of those global licenses all while keeping track of tight deadlines.

Historically, unlike with human pharmaceuticals and eCTD, regulatory professionals within the veterinary community have not had access to software solutions designed to meet their specific needs for VNeeS submissions. The lack of appropriate tools has resulted in organizations managing and tracking information across multiple spreadsheets and cross-referencing files in siloed document management systems leading to a cumbersome, error-prone, complicated, and expensive process.

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

Samarind RMS for Veterinary


 

Your Single Place of Truth™ for Regulatory Information

 

 

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




Samarind RMS Features

  • VNeesS embedded structure 
  • NVR and UPD compliant processes and workflows
  • Management of regulatory 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 reporting dashboards

 


Key Benefits

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

A bi-weekly blog for today's Regulatory Professional

Visit the blog

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

Download the fact sheet