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 with drug safety rules and regulations, EXTEDO´s team will help you to identify gaps in your pharmacovigilance processes and help you to develop and implement appropriate strategies to resolve them.
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 a PSMF is available that describes your pharmacovigilance system
Implementation and updates to SOPs covering pharmacovigilance processes
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 and improvement opportunities.
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.