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, an Italian 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.
Join the waiting list
Get notified when Chronisia becomes available and find out how it can help you automate PSUR and AIC deadlines.