Automate your Annual Product Review (APR) business process using MARS



Annual Product Review reports scheduling, management and distribution processes within organizations have been fairly ad-hoc, linear and rigid utilizing a combination of localized tools, manual steps and knowledge base from individual resources. Changing regulations in different countries, new product registrations (and withdrawals) and resource turn-over introduces tremendous challenges to organizations to ensure global regulatory commitments to agencies are met in time. The lack of centralized system or knowledge base does not offer capabilities to optimize worldwide reporting thereby increasing the overall number of reports. This increases the cost and resource needs within organizations.

Quartica’s solution can help manage the end-to-end process reporting process from scheduling to distribution and tracking of compliance metrics. The solution integrates regulatory knowledge base, company product portfolio and internal company processes to provide a centralized system. It provides automated, agile and proactive tools to organizations by reducing overall reports and ensuring regulatory commitments are met on time in a cost effective manner.


Automate scheduling and planning of APR reports.
Automate authoring of annual product review (APR) reports
Configuration tailored to organization internal standards and external regulations.
Tracking and measurement of overall compliance, delays, CAPA and overdue reports.

Ready to automate your APR business process?


Key Features

  • Manage end-to-end  reporting process including planning, scheduling, report authoring and submission tracking.
  • Generate reporting obligations worldwide based on product portfolio.
  • Optimize reporting plans utilizing harmonization strategies to reduce total overall reports.
  • Manage Review and Approval workflow process.
  • Ensure conformance to standards, templates and regulations.
  • Estimate resource and budget needs based on upcoming submissions and approvals
  • Configure organizational specific strategies to fine tune reporting plans.
  • Generate reports on variance in expected timelines and actual timelines for different levels of management.
  • Collaborate with partners and local affiliates.
  • Track decision log, review and approval history.