Plan. Monitor. Comply.
The regulatory deadlines software for the pharmaceutical industry that helps you plan, monitor, and meet every due date.
From submitting the PSUR to requesting a marketing authorisation renewal, everything is under control.
Plan, monitor, and meet every PSUR and MA renewal deadline
Chronisia is a software platform designed to automate the calculation of pharmaceutical regulatory deadlines and monitor task progress.
It combines accuracy and simplicity across three core functions: automatic deadline calculation, task assignment, and traceable reporting.
DEADLINES UNDER CONTROL
Chronisia automatically calculates deadlines for PSURs and marketing authorisation renewals according to EMA guidelines and national regulations. Each rule can be configured and customized. It can also manage other activities such as RMPs and aCOs. It eliminates typical Excel spreadsheet errors and ensures compliance with deadlines.
SYNCHRONIZED TEAM
Each activity has an assignee, a due date, and full traceability. Automatic notifications keep the team informed about new assignments, upcoming deadlines, or completed tasks. Process owners always have a complete overview, with monitoring dashboards to check workload and progress status. Collaboration becomes simple and transparent.
COMPLETE TRACEABILITY
Automatic reports, complete Audit Trail, contextual notes, and comments: Chronisia provides a full overview of each activity’s lifecycle. All actions are tracked, exportable, and verifiable at any time. A benefit not only operationally, but also during inspections, compliance is always demonstrable, with documentation ready for audits.
Compliance doesn’t happen by chance, it’s planned.
Chronisia turns deadlines into traceable, secure, and timely processes.
How Chronisia works
From planning to compliance, automating deadline management is easy.
1. CALCULATE DEADLINES
Enter your data, regulatory authorities, and attendance rules, and automatically calculate deadlines.
2. MONITOR AND COLLABORATE
Distribute tasks to your team members, receive reminders, and track task status.
3. ACHIEVE COMPLIANCE
Every action performed is logged, exportable, and available for audits or inspections.
How Chronisia helps you
Chronisia is designed to simplify the daily workload of Regulatory Affairs, Pharmacovigilance, and Quality teams, turning a complex process into a structured, automated workflow. Here’s how it supports you every day.
Reduces errors
Chronisia automatically calculates DLP dates, PSUR submission dates, and the MAH renewal application date based on EMA guidelines, sends alerts and reminders, and ensures that every task is managed on time.
Optimize team work
Each activity has a designated person, a date, and a visible progress status. Collaboration becomes simple and transparent: managers monitor the process, operators receive targeted notifications, and everyone works in sync.
Strengthens compliance
Every action is tracked in the Audit Trail, exportable and ready for audits or inspections. The system supports compliance with GVP requirements. Automatic reports, Excel exports, and notes fields enable documented management.
It saves time
With Chronisia, deadline management goes from a collection of Excel files and manual reminders to a single, structured, automated, and always-updated environment. Fewer repetitive tasks, more time for analysis and strategic decisions.
The value of a reliable solution
Chronisia was developed by Max Application, part of Abacus Group and Oracle Gold Partner: over 20 years of expertise in pharmaceutical industry with the safety database SafetyDrugs.
Validated system
Chronisia is delivered with all the required validation documentation: Validation Plan, Validation Report, Traceability Matrix, Installation Protocols, and Training Certificates. Each installation is audit-ready, ensuring full compliance and data integrity.
Data security
Max Application operates under a certified ISO 9001 and ISO 27001 Quality and Information Security Management System and complies with GDPR and NIS 2 requirements — ensuring controlled processes and data protection. For SaaS installations, data are hosted in top-tier Oracle data centres that meet the highest international standards of security, reliability, and performance. Each access is tracked, authenticated, and limited to authorized users.
Direct training and support
Training and assistance are provided directly by Max Application, the software’s developer.
A single point of contact supports clients in every phase: installation, upgrades, maintenance, and technical support.
Expertise and continuity are always guaranteed.
Frequently Asked Questions
Does Chronisia replace Excel files and manual reminders?
Yes. Chronisia is designed to move beyond the manual management of regulatory deadlines based on Excel files, separate calendars and non-traceable reminders.
The system allows teams to calculate deadlines, assign activities, receive reminders and monitor progress within a single structured environment, reducing the risk of errors, missed deadlines and outdated information.
Who can use Chronisia within the team?
Chronisia is designed to support the coordinated work of different roles within the organization. The System Administrator manages users and access rights, the Process Owner configures calculation rules, assigns activities and monitors progress, while Operators receive the activities to be performed, update their work status and complete the required actions. Each user accesses the system with personal credentials and operates according to the assigned permissions. This allows the team to work in an organized way, with clear responsibilities and fully traceable activities.
Is Chronisia a validated and audit-ready system?
Yes, Chronisia is a pre-validated system. The software is provided with all the necessary validation documentation, including the Validation Plan, Functional Specifications, Regulatory Compliance, Traceability Matrix, and Unit and Integration Test documentation.
In addition, audit trail, reports, contextual notes and comments support activity traceability and preparation for audits, inspections or internal reviews.
Is Chronisia suitable for organizations managing multiple companies or clients?
Yes. Chronisia allows the creation of independent virtual environments, designed for organizations operating on behalf of multiple companies, such as service providers, consulting firms and organizations offering Pharmacovigilance and Regulatory Affairs services. This makes it possible to manage deadlines, activities and progress separately, while maintaining an organized, traceable and distinct environment for each client.
Is Chronisia part of a broader offering for the pharmaceutical sector?
Yes. Chronisia builds on Max Application’s experience in developing software solutions for the pharmaceutical sector and is offered alongside SafetyDrugs, the pharmacovigilance database dedicated to ICSR management. The two solutions address different and complementary needs: SafetyDrugs supports pharmacovigilance case management, while Chronisia helps Pharmacovigilance and Regulatory Affairs teams plan, assign and monitor regulatory deadlines.
Ask for a demo
See how Chronisia helps pharmaceutical teams calculate Periodic Safety Reports and Marketing Authorisation renewal deadlines,
assign activities and monitor every regulatory task.