Pharmacovigilance,Vigilance & Drug Safety
With the introduction of the EU Pharma Package, the Good pharmacovigilance practices (GVP) Modules I – XVI became the gold standard for Pharmacovigilance activities. Emphasis lays on a robust, proactive risk management in order to protect patient safety and maintain compliance. Since GVP provides detailed guidance on how to implement critical pharmacovigilance (PV) processes, we use it as a basis for implementing EU- and US-tailored PV systems at low cost that surpass inspection standards by authorities and audits by customers. Our PV services relate to drugs, biologics, herbals, medical devices, cosmetics and nutritionals.
Based on the principle: “The whole is greater than the sum of its parts” and against the background of regulatory developments – the planning of your customised PV strategy is of key importance for the success of your marketed product.
Our PV system services comprise:
- Integrating pharmacovigilance into an existing quality management system or creating a timeand cost-effective quality management system for your specific needs
- Preparation of a Pharmacovigilance System Master File for EU, US or global approaches
- Written procedures and SOPs facilitating the performance of quality-assured state-of-the-art pharmacovigilance
- Signal management and continuous benefit-risk assessment (CoBRA®)
- Training for key personnel involved in pharmacovigilance activities
- Compliance monitoring of Key Process Indicators (KPIs)
- Risk-based auditing of contractual partners