Our team is composed exclusively by experienced medical doctors in the area of pharmacovigilance that can help your organisation with a range of services from case evaluation to more elaborate signal detection activities.
Marketing Authorisation Holders' EVDAS version
We can provide you with guidance and training on the use of the Marketing Authorisation Holders of the EudraVigilance Data Analysis System (EVDAS), training in the medical evaluation of electronic reaction monitoring reports (eRMRs), and line listings.
Signal Management Processes
Our consultants will help prepare the integration of EVDAS use in your current signal management processes, guiding you through every signal management step.
Write your pharmacovigilance SOPs
Have you ever experienced the (SOP) writer's block? We did, a long time ago. Now we can write clear and detailed SOPs and other Quality documents for your organisation.
Our experienced auditors can help training your Quality Assurance auditors during on site audits or via in-house training sessions so they can build their training and experience. Not every auditor is familiar with pharmacovigilance.