Chronisia: how the software manages pharmaceutical regulatory deadlines

Chronisia connects regulatory deadline calculation with the management of the activities needed to meet those deadlines. From configuring obligations by product, country and authority to assigning tasks and monitoring progress, the software provides Pharmacovigilance and Regulatory Affairs teams with a shared environment to plan, carry out and track their work. Here is how the new software developed by Max Application works and what users can do with it.

Managing regulatory deadlines means connecting products, countries, authorities, reference dates and reporting frequencies. Each obligation also involves the work required to fulfil it: planning activities, identifying those responsible, monitoring progress and documenting what has been done.

The software brings these elements together in a single process. Configured rules populate the deadline calendar; operational activities are linked to deadlines; and managers and operators have dedicated views to organise and monitor their work.

The audit trail records actions and changes, allowing users to reconstruct how the process has been managed over time. The solution also includes validation documentation to support software implementation within the organisation.

The result is a continuous link between regulatory obligations, deadlines and team activities, including across portfolios covering multiple products and markets.

The starting point is to configure the regulatory context for each product: countries where it is marketed, relevant authorities, applicable obligations and associated frequencies.

The system applies configurable calculation rules to reference dates and data, generating the required deadlines. For PSUR obligations, for example, planning takes account of applicable parameters such as Data Lock Points, submission frequencies and submission timelines. Where applicable, these include the EURD list published by EMA, which specifies frequencies, DLPs and submission dates for the active substances or combinations listed. These parameters are used to configure the schedule.

For marketing authorisation renewals, the relevant dates and calculation logic are configured according to the authorisation context. Rules can also accommodate specific conditions and exceptions applicable in different regulatory settings. Configuration therefore translates applicable requirements into logic that the system can use to populate the calendar.

When a rule or reference data item changes, the affected deadlines are recalculated based on the updated configuration. This maintains a verifiable link between the information entered and the dates generated.

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

• PSUR submission dates;
• deadlines associated with Data Lock Points (DLPs);
• marketing authorisation renewal applications;
• regulatory deadlines for the same product across multiple countries;
• exceptions or specific conditions set out in national regulations or guidelines.

You might be intersted in: How to calculate regulatory deadlines in a structured way with Chronisia

Commitment Management is the area where regulatory obligations are organised. Each commitment links a product to a specific regulatory context and to the rules governing its deadlines: for example, a periodic safety reporting obligation or a marketing authorisation renewal application.

A commitment is generated for each deadline. This structure keeps obligations associated with the same product in different markets distinct while making them accessible within a shared environment. Commitments feed into the operational calendar and the associated activities.

For users, this means being able to trace an individual deadline back to the relevant obligation and understand its context.

Deadlines calculated from commitments populate the Overall Plan, a calendar that displays regulatory obligations and how they are distributed over time.

The team therefore has a calendar view of the activities to be performed and their associated dates. Icons alongside calendar entries indicate progress, allowing users to identify, for example, activities that are in progress or overdue.

This view helps users understand the operational schedule as a whole and identify periods with a higher concentration of deadlines.

Activities are assigned in the dedicated Task Assignment screen. Here, managers can review the tasks to be performed and decide which operators to assign them to.

During assignment, managers can view each user’s workload, providing useful information for distributing activities and assessing team availability.

Deadline planning is therefore connected to work allocation: the calendar shows obligations over time, while the assignment screen allows managers to determine who will handle them.

Dashboards allow users to review the status of activities and commitments, identify tasks awaiting assignment and quickly spot activities that are overdue or at risk of delay.

Operational dashboards show outstanding activities, performance, tasks awaiting assignment and the overall status of commitments. They provide an immediate view of both day-to-day operations and indicators relevant to inspection readiness.

Pharmacovigilance and Regulatory Affairs managers need a clear view of deadlines, commitments, tasks awaiting assignment, team performance, areas of risk and traceable evidence. This visibility helps them manage the process before a delay, missed submission or inspection request brings an issue to light.

Notifications and reminders help teams keep track of activities that are approaching their due dates or are already overdue. Monitoring therefore supports task execution and helps the team maintain an up-to-date operational overview.

You might be intersted in: Regulatory deadline management: why Excel is not enough when complexity grows

Traceability extends throughout the process. Configurations, assignments, status updates, comments and task completions are recorded and remain available for review.

The audit trail allows users to reconstruct changes over time, both across the system and at individual activity level. Historical records and exportable reports support internal reviews and the preparation of evidence required during audits and inspections.

Traceability is complemented by the validation documentation included with the solution, supporting software implementation within the organisation.

The solution is designed for Pharmacovigilance and Regulatory Affairs teams within pharmaceutical companies, as well as providers managing activities for multiple clients.

The configuration can include a single company environment or multiple independent environments, accessible using the same credentials according to assigned permissions. This structure allows service providers to work across different companies while keeping their respective data and processes separate.

The demo illustrates the process through a scenario relevant to your operational context: from configuring a PSUR obligation or marketing authorisation renewal to generating deadlines, assigning activities and monitoring progress.

Ask for a live demo. The presentation shows how Chronisia organises commitments, populates the operational calendar, handles changes and recalculations, assigns activities and maintains traceable evidence through dashboards and the audit trail.

Want to know more? Visit the Chronisia website.