Cymapp® for
In a sector characterized by growing regulatory complexity and a focus on patient safety concerning the potential risks associated with device use, Risk Management becomes a crucial element for ensuring patient safety, regulatory compliance, and economic sustainability.
Pharmaceutical companies that commercialize combination products often face challenges related to integrating different regulatory systems (pharmaceutical and medical devices), which must be combined with healthcare responsibilities, particularly in:
- Integrating different regulatory standards, such as ICH Q9 for the pharmaceutical component and ISO 14971 for the technological one.
- Managing emerging risks throughout the product lifecycle, including those related to the interaction between the medicinal component and the device.
- Objectively and traceably demonstrating that the clinical benefits outweigh the residual risks, in a setting with increasingly rigorous audits.
- Monitoring the origin of a defect and understanding whether the cause of a malfunction is attributable to the device or the active ingredient, with proactive actions to address it.
These are complex technologies requiring simultaneous compliance with pharmaceutical and medical device regulations. Often, a fragmented approach to Risk Management leads to redundancies, omissions, or conflicts that emerge only in the advanced stages of development or, worse, during regulatory audits.
All advantages
Why Combination Product Manufacturers Should Use Cymapp®
- Harmonizes ICH Q9 and ISO 14971 in a single operational environment, eliminating redundancies and facilitating document consistency.
- Harmonizes ICH Q9 and ISO 14971 in a single operational environment, eliminating redundancies and facilitating document consistency.
- Correlates real-time technical risks with clinical impacts on the patient, enabling timely and targeted interventions, both pre-market and post-market.
- Keeps the risk assessment updated throughout the entire product lifecycle with full traceability, even when post-approval changes and post-marketing surveillance are required.
- Facilitates collaboration between multidisciplinary teams through a shared language and intuitive visualization tools.
Transform Risk Management
The difference between Cymapp® and other similar solutions on the pharmaceutical market is substantial
Simultaneous Compliance
With Cymapp
Facilitated Generation of Technical Documentation with Continuous Clinical Evaluation Updates and Reduced Preparation Times
Without Cymapp
Fragmented Documentation, Difficulty in Updating the Technical File
Post-Market Surveillance
With Cymapp
Structured monitoring with immediate integration of feedback into risk analysis and early identification of malfunction patterns.
Without Cymapp
Late detection of emerging problems with difficulty in analyzing post-market clinical data.
Risk/Benefit Evaluation
With Cymapp
Objective parameters for analyzing the risk/benefit ratio with intuitive visualization of correlations and quantifiable evidence for regulatory authorities.
Without Cymapp
Subjective analysis with difficulty in correlating thousands of technical and clinical data points.
Corrective actions management
With Cymapp
Intelligent prioritization of corrective actions.
Without Cymapp
Manual tracking with delays in implementation due to documents being lost within the company.