Navitas Life Sciences

Achieving complete Inspection Readiness in PV through integrated Processes, Technology, and Services

Our client, a mid-sized North American pharmaceutical company, specializing in the treatment of rare and life threatening diseases was preparing for its first NDA in both the USA and Europe. They were seeking a PV partner to support their global end-to-end PV operations. Our client was looking to:

  • Harmonize inconsistent processes and design a unified global operating model, along with the integration of new processes to ensure smooth migration of all PV data collected to date into one global safety database
  • Integrate and harmonize data from all legacy safety databases (ARISg™/ARGUS™) into a single Argus instance to enhance ongoing risk benefit assessment, safety data analysis, and signal detection processes

Read our case study and learn how we achieved complete inspection readiness in their PV Operations through integrated implementation of effective processes, best-in-class technology, and global end-to-end PV services. Our client is now benefiting from:

  • Control of their PV Operations through real-time digital oversight
  • Improved consistency of case processing and enriched data quality
  • Automated tracking
  • Regulatory compliance
  • Analytics dashboards that empower deeper insights

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