At CORONIS we comprehend that the safety of your product is of primary concern. Thus, we ensure the advanced quality of our PV services in order to respond exceptionally, even to the highest demands.
In full compliance with Good Pharmacovigilance Practices (GVP) and European and local Legislation on medicinal products (EudraVigilance), our PV experts provide excellent consultation services while giving you a great insight to your pharmacovigilance strategy planning.
Our suite of Pharmacovigilance Services includes:
- 24/7 availability of Local QPPV and Deputy Local QPPV
- Management of Individual Case Safety Reports (ICSRs)
- Preparation of Development Safety Update Repoer (DSUR)
- Development of Periodic Safety Update Report (PSUR)
- Development of Pharmacovigilance System Master File (PSMF)
- Preparation of clinical study's Safety Management Plan
- Development of Risk Management Plan
- Regulatory compliance and consulting
- Pharmacovigilance Training
- AE/SAE identification-management-reporting
- Scientific Literature Surveillance and monthly reporting
- Support on the compilation of the Standard Operating Procedures (SOPs)