Submissions Tracker

The emergence and enforcement of standards for regulated product submission 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 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.

Virtify’s Submissions Tracker product, Virtx ST can help manage the process of submissions from inception to delivery to the agency. It will help manage regulated product submissions worldwide using a precise, consistent and predictable submissions process.

• Manage regulated product submission documents, components and dependencies across products and submissions.
• View impact across submissions by establishing dependancies across products and submissions.
• Automate calculation of submission and submission component dates based on regulatory commitments to Agencies
• 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)

• Facilitate regulatory compliance of commitments to agencies on time.
• Manage projects, resources and commitments by performing impact analyzes.
• Generate reports on variance in expected timelines and actual timelines for different levels of management.
• Determine the resource load across products and submissions.
• Ensure conformance to standards, templates and regulations.