Professional Pharmacovigilance Services

Our services cover a broad spectrum within the Pharmacovigilance area from general system maintenance to daily data management i.e.:

• Total outsourcing of all your Pharmacovigilance activities
• Data entry and expedited reporting of single cases to Competent Authorities
• Pharmacovigilance aspects of co-licensing/co-marketing/co-promotion agreements
• Preparation and evaluation of your Pharmacovigilance system
• Preparation of Periodic Safety Update Reports/Summary Bridging Reports/Addendum Reports/Annual Safety Reports
• Literature screening
• Preparation and maintenance of EU risk-management plans
• Provide Qualified Person for Pharmacovigilance (QPPV) and deputy