New Products & Market Expansion
When your product portfolio or geographical footprint changes.
Pharmacovigilance System Master File
A Pharmacovigilance System Master File (PSMF) must remain accurate as your organisation evolves.
More Than a Document. A Living Reflection of Your PV System.
New products, changes in Qualified Person for Pharmacovigilance (QPPV) responsibilities, vendor transitions, acquisitions and technology updates can all affect your pharmacovigilance system. Bpharma provides structured lifecycle support to help keep your PSMF current, consistent and ready for regulatory inspection.
In detail
When should your PSMF be reviewed?
Mergers & Acquisitions
When PV systems, responsibilities or portfolios are integrated or transferred.
Organisational & Vendor Changes
When QPPVs, service providers, governance structures or PV processes change.
System & Technology Changes
When safety databases, interfaces or critical computerised systems are implemented or modified.
Process
Our approach
Assess
Review PV system and requirements.
Collect
Gather and verify system information.
Develop
Prepare main body and annexes.
Validate
Cross-check with PV stakeholders.
Maintain
Control changes and updates.