Improve your internal processes and ensure compliance with pharmacovigilance regulations.
EXTEDO’s Pharmacovigilance Business Process consulting services are tailored specifically to your needs. Based on many years of experience working hands-on with drug safety rules and regulations, EXTEDO´s team will support you in all aspects of your pharmacovigilance activities.
Optimize processes and interfaces to ensure a proper and timely handling of mandatory activities
Ensure compliance through a full understanding of current and upcoming pharmacovigilance requirements
Ensure your procedures are up to date, optimized and compliantly reflected in your PSMF
Technical and operation support to meet your pharmacovigilance workload
A pharmacovigilance system is a complex network of processes with numerous tasks and responsibilities. Changes in legal requirements or internal structures necessitate rework and adaption of these processes. Similarly, updates to technical infrastructure, e.g. a new safety database, may also trigger process changes. EXTEDO will analyze your pharmacovigilance processes and will highlight any gaps. We will align with your business operating model to identify improvement opportunities and help you implement appropriate strategies to perform them.
Based on your needs and the results of our gap analysis, EXTEDO will provide individual best practice consultancy. Working together with your experts, EXTEDO will identify optimization opportunities for your pharmacovigilance processes and resources. In addition, we will provide advice on concrete improvement possibilities and how to implement them.
With pharmacovigilance systems being complex and consisting of many different processes and tasks each organization will have their own priorities as to which changes need to be made first. We provide you with the guidance you need to make these critical decisions, and to implement your chosen solution.
EXTEDO’s team can support you with your daily pharmacovigilance tasks and activities by providing you with additional qualified technical assets to address your routine pharmacovigilance operations or to cope with an emerging one-off project of yours that brough an unanticipated increase in your workload. Our team has hands-on experience and many years of expertise in drug safety and can reliably assist you in meeting your regulatory compliance targets even with high project payloads and complexities.