The experience of our team members allows us to offer the following Pharmacovigilance supports to our clients:

Redaction:

• Quality system: procedures redaction / review
• Pharmacovigilance System Master File (PSMF)
• Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)

Management and submission:

• Case review (ICSR) and coding in EudraVigilance
• Medicinal products coding in EudraVigilance
• Weekly literature review

Support:

• External auditor