- Preparing for a regulatory inspection or client audit
- Launching a new product or entering new markets
- Going through a merger, acquisition or portfolio transfer
- Establishing or redesigning a pharmacovigilance system
- Transitioning between vendors or service providers
- Implementing or migrating a safety database
- Responding to significant regulatory changes
- Following up on audit or inspection findings
- Experiencing compliance concerns, recurring deviations or operational challenges
Pharmacovigilance Consulting and Gap Analysis
Is your pharmacovigilance system truly compliant or simply assumed to be?
Know Your Gaps. Reduce Your Risk. Stay Inspection-Ready.
As regulations, portfolios, partnerships and operating models evolve, gaps can emerge between regulatory requirements, documented procedures and day-to-day practice.
Gap analysis provides an independent, expert assessment of your pharmacovigilance system to identify compliance risks, operational weaknesses and improvement opportunities before they become audit or inspection findings.
PV gap analyses are particularly relevant following launches, acquisitions, regulatory changes and previous audit findings.
Key points
When should you consider a PV gap analysis?
A proactive PV gap analysis can provide particular value when your organisation is:
Process
From gap identification to compliance
Understand
We define your scope, products, markets, regulatory responsibilities, operating model and key areas of concern.
Assess
Our PV experts review relevant documentation, systems, processes and compliance data and conduct interviews with key people.
Identify & Prioritise
We identify gaps and assess their potential regulatory, quality and operational impact, allowing attention to be focused on the areas that matter most.
Recommend
For every relevant gap, we provide practical recommendations and proposed remediation actions.
Remediate
Where required, Bpharma PV can continue beyond the assessment and support implementation of the remediation plan — from standard operating procedure (SOP) and Pharmacovigilance System Master File (PSMF) updates to process redesign, training and broader PV system improvements.
Whether you need a focused assessment of a specific PV process or an end-to-end review of your global pharmacovigilance system, our approach is tailored to your organisation, products, markets and risk profile.