Safety-report management
Collection, recording, and processing of cases.EudraVigilance and EUDAMED management.
Pharmaco
From the design of the risk management plan to the collection and management of reports, through to full-service outsourcing.
Service scope
Operational product-safety management.
The activities are designed in accordance with company procedures and GVP.
Medical Device Risk Management
Design of the Post-Market Surveillance PMS and PMCF.
Risk oversight
Monitoring of EudraVigilance and literature.Preparation of PSURs and PBRERs.
Full-service outsourcing
Management of all pharmacovigilance activities on behalf of the client, assumption of the LQPPV role.
Tell us about your project.
For operational details, scope and support arrangements, contact Nextrasearch directly.