Our Pharmacovigilance department specializes in the implementation and optimization of customized PV systems. Together with you, we develop individual solutions to set-up the optimal PV system tailored to your company size/product portfolio. Our team also helps you to manage and monitor all routine safety aspects of your medicinal product(s).
The aim is the safer and more effective use of medicines for everyone. It involves all activities that relate to noticing, assessing, understanding, managing and preventing adverse effects of medicines for individuals and populations.
From the moment a marketing authorization is applied for and throughout the life of a medicinal product, safety monitoring is an obligation.
Our team helps you to manage and monitor the post-marketing phase of your medical device products so that it meets the local country regulations.:
- Post-market signal detection to identify problematic events regarding your device
- Local and global literature reviews
- Regulatory and safety database searches
- Periodic safety update report preparation
- Update of clinical evaluation reports
- PV case processing (recordings, database entry, case translation and follow-up)
- Establish causality assessment for PV cases
- Submission to competent authorities
- Literature review
All these activities are carried out in full compliance with Good Vigilance Practices and local standards.
We can provide a complete service designed to meet the complex and changing needs of the our region, for both medicinal products and medical devices.
We provide the following services:
- Post authorization
- Medical device vigilance
- Auditing and training