Product Vigilance

Our mission is to provide the highest quality consulting services to all our clients in the Pharmaceutical medicines and devices sector. We emphasise a commitment to client satisfaction via appointment of our accomplished consultants to all projects.

• Provision of the Responsible Person for EudraVigilance (investigational products)


• Maintenance of Product in EudraVigilance Medicinal Product Dictionary (XEVMPD)


• Provision of the EU Qualified Person for Pharmacovigilance and deputy, including comprehensive 24-hour availability


• Design, implementation and provision of global pharmacovigilance systems


• Pharmacovigilance System Master File


• Standard Operating Procedures


• Preparation of the EU Risk Management Plan, FDA REMS


• Training


• SDEAs


• Design and implementation of risk minimisation activities e.g. patient registry


• Pre-inspection audits and preparation for Agency pharmacovigilance inspection


• Preparation and submission of PSUR/PBRER, PADER, ASR, AR, DSUR