pharmacovigilance consultancy services
By the time PV becomes urgent, the right help is hard to find.
Inspections. Commercial launches. Partnership diligence. Vendor failures. UBC’s consulting practice is built for these big pressure moments - bringing an experienced PV leader into complex situations quickly, with clear scope, defined outcomes and the perspective that our consultants have supported and delivered in similar scenarios.
Because some situations can’t wait, we’re ready to engage within five business days.
18+ years
average industry experience
120+
countries covered through global PV operations
99.6%
on-time submissions to health authorities
0
critical findings across inspections directly supported by UBC (2023–2025)
Talk to a PV leader
“An inspection, a launch, a diligence request - the specifics change, but the pressure is often the same. People need an experienced view on the situation, confidence in the next steps, and a clear understanding of where the real risks sit.”
Tom Coles
Director - Pharmacovigilance Process Excellence
Services
The moments that bring
people to us
The pressure is rarely caused by not knowing there’s a problem. It’s caused by not knowing how serious it is or what happens if it’s left alone.
That’s usually when the phone rings.
Inspection
“We have an inspection in 90 days and our PSMF hasn’t been touched in two years.”
An inspection doesn’t start when inspectors arrive.
It starts months earlier – in the documentation, governance, decisions, and habits sitting behind the system. By the time the notice lands, the opportunity to influence the outcome is already shrinking.
The calendar is unforgiving and the consequences are public. Teams often know where the weaknesses are. What they need is an experienced view on what matters most, what can wait, and what needs attention now.
Where we typically help
- Mock inspections with experienced reviewers
- PSMF review and optimisation
- Front room / back room preparation
- QPPV and process-owner coaching
- CAPA design and effectiveness verification
Launch
“We’re 18 months from launch and the PV system that got us through development won’t get us through commercialization.”
Most launch readiness problems are visible long before launch.
The challenge is knowing which ones will create pressure later. New markets, new obligations, new reporting requirements, new stakeholders. The closer launch gets, the less room there is to redesign the foundations.
The strongest systems aren’t built all at once. They’re built with a clear view of what comes next.
Where we typically help
- Launch readiness assessments
- PV operating model design
- Aggregate reporting and compliance planning
- Risk management planning (RMP / REMS)
- Global process and governance development
DILIGENCE
“Our partner’s diligence team flagged our signal management process and the deal is at risk.”
PV diligence findings rarely stay inside PV.
They affect valuation, confidence, timelines, and negotiations. What begins as a technical question can quickly become a commercial one.
When scrutiny arrives, the quality of the answer matters just as much as the answer itself.
Where we typically help
- Buy-side and sell-side PV diligence
- Signal management reviews
- Gap assessments and remediation planning
- Governance and compliance health checks
- Integration planning and risk mitigation
VENDOR
“Our CRO is missing things and I can’t answer the regulator’s question about how I know.”
You can outsource the work. You can’t outsource accountability.
When regulators ask how performance is being monitored, the answer can’t be, “our vendor handles that.” Oversight requires visibility, governance and confidence that the right controls are working as intended.
The problem isn’t always the vendor. Sometimes it’s the absence of a clear view across the system.
Where we typically help
- Vendor oversight framework design
- SDEA review and optimisation
- Vendor governance and performance monitoring
- Audit preparation and support
- Corrective action and remediation programmes
Scaling
“My CEO is asking PV questions in key meetings, and I don’t know exactly where to get the most comprehensive answers for them.”
There comes a point when operational support is no longer enough.
Board discussions, regulator interactions, partnership negotiations, and safety concerns often require a different level of experience. Not because the team isn’t capable, but because the stakes have changed.
Some conversations are easier when you’ve had them before.
Where we typically help
- Strategic PV advisory
- Interim PV leadership support
- Board and executive briefings
- Regulatory interaction preparation
- Governance and oversight frameworks
Discovery
“A new investor asked questions nobody could answer.”
Most PV systems evolve gradually.
New products are added. New vendors come online. New markets are entered. Processes adapt. Teams change. Over time, complexity accumulates. What once felt clear becomes harder to see. Risks emerge in the gaps between processes, responsibilities, and assumptions.
Sometimes the most valuable thing is understanding where you stand before somebody else asks.
Where we typically help
- PV health checks and maturity assessments
- Compliance gap analysis
- Risk identification and prioritisation
- SOP and governance reviews
- Remediation roadmaps
Built for situations that don’t allow a learning curve
Most consulting firms start with discovery. Our practice is built around situations we’ve seen before. That experience shapes how we scope work, how we structure engagements and how quickly we can start creating value.
Senior practitioners from hour one
The people who scope the work stay involved in delivering it. No handoff. No layers of junior resource between the client and the expertise they came for.
Fixed scope. Fixed fee. Defined outcome.
Most consulting is sold by the hour. Our engagements are designed around clear deliverables, timelines, and outcomes from the start.
Inspection-ready by design
We design and strengthen PV systems with inspection readiness in mind. From PSMF content and governance frameworks to oversight models and documented decision making, the goal is a system that stands up to regulatory scrutiny.
Built around proven engagement models
Not every situation is unique. Inspection readiness, launch preparation, vendor oversight and diligence reviews all follow recognisable patterns. The benefit of having seen them before is knowing where to start.
Three ways to engage
Not every situation needs the same response
Some situations need a focused piece of work. Others need ongoing access to experienced counsel. Occasionally, they need both.
We’ve built our consulting practice around clear engagement models, so clients know what they’re getting, what it costs, and what success looks like from the outset.
Advisory Support
Focused Project
Embedded Expertise
Best For
Best For
Ongoing access to senior counsel
Best For
A specific challenge with a defined outcome
Best For
Periods of growth, transition or operational pressure
Typical situations
Typical situations
Governance support, strategic planning, executive counsel
Typical situations
Inspection readiness, diligence, vendor oversight, launch preparation
Typical situations
Launches, remediation, capability building
Time to start
Time to start
Engageable within 5 business days
Time to start
Engageable within 5 business days
Time to start
Based on availability and scope
Deliverables
Deliverables
Agreed advisory cadence
Deliverables
Defined upfront
Deliverables
Dedicated senior resource
Outcome
Outcome
Ongoing strategic support
Outcome
Clear scope, timeline and endpoint
Outcome
Embedded leadership and execution support
case studies
Experience in practice
Oncology / Advanced Therapies
Global PV Training Programme
A global PV team needed a clearer understanding of evolving EU GVP requirements.
- Strengthened understanding across geographically distributed teams
- Improved alignment with evolving regulatory expectations
- Enhanced inspection readiness and compliance awareness
Oncology / Rare Disease
Global PV System Design
A growing biotech required a scalable PV framework capable of supporting increasing regulatory obligations.
- Established a structured global PV operating model
- Defined governance, accountability, and data management processes
- Created a framework capable of supporting continued growth
Ophthalmology / Medical Device
PV Framework Build
An organisation with limited internal infrastructure needed a compliant foundation for PV operations.
- Implemented a fit-for-purpose SOP framework
- Reduced compliance risk through defined ownership and workflows
- Improved readiness for future regulatory scrutiny
FAQS
Early conversations usually focus on the same few questions.
What's included in UBC's full-service pharmacovigilance offering?
Can UBC act as our safety department, or only as a vendor?
Both. For many emerging biotechs, UBC operates as the safety function itself – helping make hiring decisions, author SOPs, select safety databases, and build the processes needed to scale as adverse event volumes increase through development. For larger sponsors, UBC more often supports a defined area such as case processing, aggregate reporting, or signal management alongside internal teams. The right model depends on how the function is structured and where accountability sits.
How does UBC compete with offshore case processing on cost?
By being clear about where each model fits. Offshore teams are well suited to high-volume, lower-complexity case processing where speed and cost are the primary drivers. UBC’s full-service model is built for therapies where adverse events are clinically serious, the case mix is more complex, or the science is still emerging – including rare disease, cell and gene therapy, oncology, paediatrics, and psychedelics. We work with offshore partners where it makes sense, but most sponsors are paying for judgement at intake and during signal review, not data entry.
What technology does UBC use for case processing?
UBC operates a fully cloud-based Oracle Argus environment, supported by validated tools for literature screening, signal detection, and regulatory submissions. Automation helps reduce manual handling and shorten triage times, allowing teams to focus attention where judgement matters most. The technology is consistent with industry standards. The difference is the expertise behind it – the people making decisions, identifying risks, and ensuring the work stands up to scrutiny.
How does UBC handle signal detection and management?
UBC combines aggregate-level signal detection with case-by-case clinical review to identify potential safety concerns, assess their significance, and determine when further investigation or regulatory action may be needed. Our approach aligns with FDA guidance, EMA GVP Module IX, and CIOMS VIII, drawing on broad data sources and appropriate patient populations to ensure signals are interpreted in the right clinical context.
What does UBC's compliance track record actually look like?
From 2018 through Q2 2025, UBC supported 30 regulatory inspections with no critical findings. More than 99% of regulatory submissions are delivered on time, across 70,000+ cases processed annually. Those numbers reflect something important: systems perform better under scrutiny when they’re shaped by experienced people from the start, not assembled under pressure.
How does UBC support periodic and aggregate safety reporting?
UBC prepares PADERs, PSURs, PBRERs, and DSURs throughout the product lifecycle – from the more frequent reporting required for new therapies through to annual reporting as the safety profile becomes better understood. The work is led by clinicians with advanced degrees, with a focus on reports that tell a clear benefit-risk story rather than simply restating the data.
You don’t need a fully defined scope or a statement of work.
Start with the challenge, the question or the concern that’s prompting the conversation. We’ll help you determine whether action is needed, where the priorities sit and what a practical response looks like.
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