Make regulatory intelligence drive regulatory affairs business processes



Over the last decade, regulatory agencies worldwide have gradually developed regulations and laws to regulate drug development processes in a consistent manner. As more counties 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. Organizations currently do not have a centralized process to manage tracking, maintaining and distribution of the various rules and regulations. The current processes utilize a combination of tools, external system and websites 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 regulations worldwide 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 country based roles access allowing individual countries to update and publish their regulations set.


Manage global mandates, regulations and internal organizational policies and procedures
Communicate analysis of international, regional and national safety regulatory reporting requirements .
Manage summary and position papers including responses to regulatory documents.
Manage internal assessment, review and approval of updates to regulations.

Ready to automate your Regulatory Intelligence management process?


Key Features

  • One stop shop to manage worldwide mandates, regulations and guidelines.
  • Support to track internal company policies and guidelines.
  • Interactive map based view color coded based on strength of regulation in the country.
  • Re-use meta-data, fields and data across globally.
  • Version history to track all changes and effective documents.
  • 21 CFR Compliant with built in audit trial, security and confidentiality protocols.