The professionals at Zwiers have the experience and skills to ensure the highest quality PV
From early development through the post-marketing phase
We live quality and compliance and make sure your business and patients settle for nothing less than the highest standard
Our PV services
Pharmacovigilance (during development and post-marketing)
- Responsible Person (RP) for EudraVigilance(EV) services (clinical trials)
- European Qualified Person for Pharmacovigilance (EU QPPV)/ deputy EU QPPV services
- EudraVigilance (creation of EudraVigilance accounts)
- Data entry and maintenance of Article 57/xEVMPD (extended EudraVigilance medicinal product dictionary)
- Writing and maintenance of Pharmacovigilance Master File (PSMF)
- Setting up PV system in line with good pharmacovigilance practices (GVP) and current regulations
- Local person for Pharmacovigilance (LPPV) / deputy LPPV services in the Netherlands
- Global and local literature monitoring
- Safety data management (including ICSR and SUSAR reporting)
- Preparation of aggregate reports such as Periodic Safety Update Reports (PSURs), and/or Development Safety Update Reports (DSUR)
- Preparation of Risk Management Plans (RMPs), educational materials
- PV trainings
PV Auditing
- GVP auditing (remote or on-site) of marketing authorisation holders (MAH) and/or partners
- Risk-based questionnaires
- Creation of strategic audit plans including accompanying procedures
- Support during inspections and/or performing mock-inspections of PV system
Meet with Zwiers! Contact us
We have offices in Oss and Amsterdam
Zwiers Regulatory Consultancy is a ProductLifeGroup Company
ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.
