OZQA PRODUCTS

PRE-FILLED DOCUMENTS

Browse all available document templates designed to help organizations establish compliant systems efficiently and support regulatory readiness and EU regulatory expectations.

PV Documents

Pharmacovigilance (PV) document templates supporting EU GVP-compliant PV systems for pharmaceutical and biotech companies. The templates help organizations preparing for EU marketing authorization establish key PV documentation, including the Summary of the Pharmacovigilance System (SPS) and the Pharmacovigilance System Master File (PSMF) required at the time of submission.

6 products

Summary of the Pharmacovigilance System (SPS)
Price€189.00
Excluding VAT
LOG FORM: EU-QPPV Availability Test
Price€189.00
Excluding VAT
Phase III & Marketed Products

LOG FORM: EU-QPPV Absence and Deputy Coverage Record
Price€189.00
Excluding VAT
SOP: EU-QPPV and Back-up Coverage
Price€985.00
Excluding VAT
Phase III & Marketed Products

SOP: PSMF Maintenance
Price€985.00
Excluding VAT
Phase III & Marketed Products

Pharmacovigilance System Master File (PSMF)
Price€1,985.00
Excluding VAT