REGULATORY AFFAIRS
SUITE

Regulatory Affairs Solutions

Quartica’s MARS platform provides end-to-end solutions to manage the complex regulatory affairs business processes. The solutions can extend, enrich and enhance your existing regulatory systems (e.g. RIMS) enabling automation and eliminating manual steps thereby reducing the chance for delays or errors. The solutions provide the capability for contribution and collaboration across different regulatory affairs domains facilitating automation and improving compliance.

Solutions

Common Technical
Documentation (CTD)

Labeling Documents

CMC Change Assessments

Ad/Prom Materials

Benefits

One stop shop to manage worldwide regulatory submissions, regulations and guidelines
Communicate regulatory changes to international, regional and national stakeholders
Ensure organizational conformance to standards, templates and regulations
Generate pre-configured reports to review KPIs, quality and compliance metrics

Ready to Automate your regulatory affairs processes?

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