Optimize regulatory submissions business processes using MARS



The emergence and enforcement of standards for regulatory submissions worldwide over the last few years have been gradually introducing consistency and standardization. The ad-hoc nature of submissions in the past was fairly unpredictable from a timeline, resource, and infrastructure perspective. This coupled with parallel submissions, dependencies and multiple product lines introduced tremendous challenges to ensure regulatory commitments to agencies are met in time. The ability to allocate the right resources with the correct skill sets across submissions and products is a challenging endeavor.

Quartica solution can help manage the process of submissions from inception to delivery to the agency. It will help manage regulatory submissions worldwide using a precise, consistent and predictable submissions process.


Automate scheduling and planning of regulatory submissions
Automate authoring of regulatory documents and reports.
Generate pre-configured variance, KPI and timeline reports
Ensure conformance to standards, templates and regulations.

Ready to optimize your regulatory submissions process?


Key Features

  • One stop shop to manage submission planning authoring and distribution.
  • Manage submission documents, components and dependencies across products and submissions.
  • View impact across submissions by establishing dependencies across products and submissions.
  • Automate calculation of submission and submission component dates.
  • Re-calibrate dates based on changes at any stage in the timeline.
  • Baseline transition timeline of document(s) from one stage to another. (Ex: QoS Drug Substance document)