Pharmacovigilance, a complex process needed to demonstrate risk/benefit ratio of each product, it is a priority and a duty for all pharmaceutical companies. Moreover, medicinal products cannot be marketed within the EU without following European law, so we are a smart solution to comply with European and local laws and regulations.
Our Pharmacovigilance team can support you in pharmacovigilance activity thanking to our long-lasting experience gained by helping companies in managing these activities in Europe. Our working team is made of skilled and updated personnel who provide you with very qualified services in a timely way, tailored to your specific requirements.
How can we help you?
We offer the Pharmacovigilance service in outsourcing; so that we can provide a solution in the following activities:
- Provision of EUQPPV role
- Drug safety officer
- Periodic Safety Update Report (PSUR)
- Risk Management Plan (RMP)
- Pharmacovigilance System and Pharmacovigilance System Master File (PSMF)
- Eudravigilance screening
- Entry of adverse reaction reports into EudraVigilance
- Managing of ICSR and their follow-up
- Regulatory intelligence website screening (AIFA ed EMA)
- Managing of Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
- Monitoring of medical literature local and International
- Running of specific literature search as per pharmacovigilance
- Building up the adapt searches as per pharmacovigilance
- Signal Detection
- Pharmacovigilance in the clinical trials