Optimize your regulatory Ad/Prom business processes using MARS

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AD/PROM

Over the last decade, regulatory agencies worldwide have gradually developed regulations and laws to regulate Ad/Prom process. As more countries adopt these practices there is a large set of rules and regulations that are both global and local in a constant state of evolution and change. The current processes utilize a combination of tools, external system and human resources to collate the information. This process is manual, error-prone involving repetitive work with a high degree of risk and non-compliance. As the scale of operations grow, the potential for delays, errors, or loss of communication of critical information increases.

Quartica’s solution can help organizations manage global and local Ad/Prom information in a centralized collaborative system. Organizations can manage up-to date information with history of changes and ensure all stakeholders within the company have access to the latest information. The system also provides support for documentation summaries including responses to regulatory documents.

Benefits

Manage Ad/Prom concepts, pieces, kits and kit components in a centralized collaborative audit trailed environment.
Communicate changes to Ad/Prom information to international, regional and national stakeholders​.
Manage supporting Ad/Prom documentation, summaries including responses to regulatory documents
Generate pre-configured reports to review KPIs, quality and compliance metrics.

Ready to optimize your Regulatory Ad/Prom business process?

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Key Features

  • One stop shop to manage regulatory Ad/Prom concepts, pieces and PRB information.
  • Support to track Ad/Prom Kits and Kit components including any dependencies.
  • Support for PRB review and approval workflow.
  • Pre-configured cycle time, critical dates and period management reports.
  • Support to track key life cycle milestones for an Ad/Prom Piece.
  • 21 CFR Compliant with built in audit trial, security and confidentiality protocols.