Quartica Life Sciences Solutions

REGULATORY AFFAIRS

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.

Ad/Prom

Over the last decade, regulatory agencies worldwide have gradually developed regulations and laws to regulate advertising and promotional processes. 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….

Submissions

The emergence and enforcement of standards for regulatory submissions worldwide over the last few years has 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….

CMC Change Assessments

The current processes for dissemination of information pertaining to updates to CMC Change assessments is labor intensive, inconsistent, and rely upon the efforts and knowledge of individuals. The existing processes for dissemination of a change and tracking relies on manual processes including face to face meetings, e-mails and conference calls. This is highly inefficient and is prone to error….

Regulatory Intelligence

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….

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

Key Features

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