eCTD submissions are one of the key steps in the development of pharmaceuticals. What if you miss your product launch due to a delay in eCTD submissions? The cost of lost opportunity per day delay in the product launch is expected to be in the millions. Subsequently, the cost of non-compliance to the Health Authority (HA) timelines and regulations is huge. With the fast-approaching submission deadlines for multiple products in their portfolio, life science companies often struggle to efficiently plan, execute, and track their submission activities. The involvement of various systems & stakeholders across disciplines and geographies makes preparing compliant submissions on time even more complex. Changing regulations and the competitive pressures to launch products simultaneously in multiple regions demand not only strategic submission planning in place but also the ability to closely track the progress toward the successful execution of the submissions.

Submissions Tracker for Comprehensive Outlook of eCTD Submissions

A user-friendly automated system for planning & tracking complex global eCTD submission activities, activity workflow management, and storing & managing Regulatory applications and submission information is a must to ensure applicants meet the associated challenges well before time. Getting visibility into submission & publishing operations at a granular level makes the whole process of submissions smoother and faster.

Submission Tracking

Submission planning & tracking streamlines the process of submissions and publishing. Effective planning and tracking all the associated submission operations are paramount in publishing fully compliant and on-time submissions. The end-to-end tracking and tracing of Regulatory submissions drive an inquisitive process that enables users to find an effective way to administer Regulatory submissions operations and overcome challenges in the pathway. Subsequently, it clarifies the activities, timelines, and dependencies for all the global teams.

A robust submission tracker accelerates eCTD submissions by:

• Enabling users to plan submissions activities and track the Regulatory authorities’ interactions
• Capturing submission information and relevant data
• Tracking issues related to submissions and managing resources
• Offering powerful audit trails and dashboards for submission tracking metrics
• Generating reports for submissions based on compliance and non-compliance, as well as specific task-based reports for users
• Enabling automatic email notifications, reminders for upcoming submissions, and overdue notifications for due date crossed submissions
• Tracking the number of submissions deadlines, and helps you define priority tasks
• Configuring due dates for real-time alerts and notifications to the users involved in submissions
• Creating efficient submission workflow, submission archival, and reuse
• Creating efficient document workflow, document archival, and reuse

Using a submission planner, rich dashboards, reporting, and detailed activity tracking, a submission tracker captures all the relevant submission information, including metadata, and reports back the data and insights as per the user’s requirements.

Freyr SUBMIT Track is a lightweight web-based application and a one stop shop that enables you to plan and track your end-to-end submission operations in one place, giving a holistic view of your submissions across the globe. It gives Regulatory teams confidence to meet considerable challenges faced with the widespread eCTD mandates across the globe.

Reach out to Freyr experts to stay informed on submission progress and ensure that important deadlines are never missed.