In the modern regulatory landscape, risk management is no longer an optional add-on; it is central to compliance. ARIREX provides integrated Quality Risk Management (QRM) solutions aligned with ICH Q9 principles, helping you make science-based decisions that prioritize patient safety.
We assist in establishing QRM frameworks that are embedded into your Quality Management System. From facilitating complex risk assessments (FMEA, HACCP) to developing risk management plans, we ensure your approach is proactive rather than reactive.
Integrated Risk Solutions
Our experts facilitate objective risk assessments that identify potential failures and implement effective controls.
- Quality Risk Management (QRM) Process Implementation.
- Risk Assessment Facilitation (FMEA, PHA, HACCP).
- Risk Management Plans and Reports.
- Integration of Risk into Change Control and Deviations.
- Risk-Based Audit Program Development.
Science-Based Decisions
Effective risk management leads to more focused resource allocation and better regulatory outcomes.
- Patient Safety: Ensure that product quality risks are understood and controlled.
- Regulatory Alignment: Meet the increasing expectations for risk-based thinking from global agencies.
- Proactive Prevention: Identify and mitigate issues before they result in quality failures.