Pharmacovigilance

We understand the importance of the pharmacovigilance requirements for your product. Our experienced staff (including an in-house physician) are committed to on-time, high quality service.

• Provision of EEA QPPV and deputies
• RMPs, PSURs, PSMFs, DSURs (advice and writing)
• Electronic reporting of SUSARs and ADRs to EMA and European Competent Authorities (clinical trials and post-marketing cases)
• Performing literature searches
• Preparation of client-tailored pharmacovigilance SOPs
• XEVMPD support

We have a validated ICH E2B compliant database to assist in the reporting activities.