How to calculate regulatory deadlines in a structured way with Chronisia

When calculating regulatory deadlines, error is a structural risk: an outdated rule, a misaligned piece of data, or a regulatory change can generate incorrect deadlines with significant operational impacts. The risk increases with the increase in products, countries, and regulatory requirements, making it increasingly difficult to maintain control and consistency over time. Chronisia was created precisely to reduce this criticality and restore control over the process.

Chronisia is a regulatory deadline calculation engine designed for the pharmaceutical industry.
It operates across three main levels: deadline calculation, operational task management, and full process traceability.

The calculation of regulatory deadlines is based on the application of configurable rules to product data and the relevant regulatory authorities.

For each product, the system uses information such as marketing authorization status, Data Lock Point (DLP), active substance, regulatory authority, and regulatory context, linking these elements to the frequency rules defined by applicable guidelines and regulations.

Based on these inputs, the calculation engine applies timing logic, manages any exceptions, and automatically generates the deadline schedule.

The result is a consistent and up-to-date set of deadlines, including:

• PSUR submission deadlines
• Data Lock Point (DLP) timelines
• Marketing Authorization (MA) renewal deadlines
• Multi-country regulatory schedules
• Exceptions and specific conditions defined by local regulations or guidelines

Once deadlines are generated, the system automatically translates each deadline into operational tasks that can be assigned to team members based on roles and responsibilities.

For each task, the system defines the responsible person, timelines, and status, allowing managers to continuously monitor progress and intervene when needed.

The system also supports day-to-day operations through automated notifications for upcoming or overdue tasks, facilitating coordination between Regulatory Affairs and Pharmacovigilance teams and reducing the risk of delays or misalignment.

Every activity generated by the system is recorded and tracked over time. Chronisia maintains a complete history of operations, including assignments, updates, and task completion, through audit trails and exportable reports.

This allows responsible teams to maintain full visibility over deadlines and demonstrate proper process management during audits or inspections.

In many organizations, regulatory deadlines are still managed through Excel files, shared calendars, and manual reminders. This approach may work in limited contexts but becomes increasingly fragile as the number of products, countries, and regulatory requirements grows.

The main challenges include errors or missed deadlines, difficulty keeping rules up to date, and misalignment across files and versions, leading to inconsistencies. These issues are often compounded by misalignment between Regulatory Affairs and Pharmacovigilance teams and the lack of structured traceability.

Without a system that consistently applies rules over time, deadline calculation inevitably remains fragile.

Chronisia was designed to address this need. The system automates the generation of deadlines while maintaining full control over the entire process lifecycle.

Deadlines become the result of a system that applies defined and verifiable rules. This approach allows Regulatory Affairs and Pharmacovigilance teams to reduce operational risk, improve internal coordination, and maintain a clear, centralized, and up-to-date view of regulatory activities.

To understand how Chronisia can fit your operational context, you can request a personalized demo. We will show you how to automate the calculation of your regulatory deadlines, improve control, and reduce operational risk with Chronisia.

Contact us to request a demo and evaluate how to move from manual management to a structured and traceable system.