Quality is at the core of all activities carried out by Expert Med.
We have implemented an integrated quality management system that ensures continuous operational control and compliance with Good Distribution Practice (GDP) requirements.
Pharmacovigilance – Commitment to Patient Safety
We support an active system for the collection and management of relevant information regarding the safety of medicinal products. We treat with the utmost seriousness any information that may impact patient health and act promptly whenever the situation requires.
Adverse Event Reporting
We encourage the reporting of any suspicions regarding adverse reactions or quality issues.
Each notification is analyzed in a structured manner, and whenever necessary, appropriate procedures are initiated and the competent authorities are informed.
Expert Med has a designated responsible person for pharmacovigilance and the management of safety notifications.
Pharmacovigilance Contact:
Email: farmacovigilenta@expert-med.eu
Phone: +40 726 103 741
Complaints Management
We have implemented a clear process for the rapid investigation of complaints and the identification of root causes. When a deviation is confirmed, we adopt corrective and preventive measures to support continuous improvement.
When a deviation or a potential risk associated with the product is confirmed, appropriate corrective and preventive actions (CAPA) are adopted, aimed at eliminating the identified cause and preventing the recurrence of the situation. These actions are monitored and periodically evaluated to ensure their effectiveness and to support the continuous improvement process.
Product Recall
We have operational mechanisms that allow the rapid identification and controlled withdrawal of products from the distribution chain, if the situation requires it.
We ensure immediate communication with the competent authorities and with all involved partners in order to guarantee full traceability and the efficient completion of the withdrawal process.
All withdrawal actions are fully documented and monitored by the Responsible Person.
Prevention of Falsified Medicines
We apply strict measures to verify the authenticity of products and comply with European serialization requirements, contributing to the security of the pharmaceutical supply chain.
If there are suspicions regarding the falsification of a medicinal product, it is immediately isolated and stored separately, and all relevant actions and observations are properly documented. The competent authorities and the Marketing Authorization Holder are promptly informed, in accordance with internal procedures and applicable regulations.