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Vendor oversight that stands up to inspections, and the person behind it.

Paulina Valuskova, Ph.D. leads this practice. A pharmacist and researcher by training, with postdoctoral experience at the University of Glasgow and the University of Michigan, her career spans hands-on Pharmacovigilance (PV) operations, audit strategy, regulatory intelligence, and Deputy QPPV responsibilities. She brings the kind of end-to-end PV understanding that makes vendor oversight genuinely effective, not just documented.

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Quality systems built to satisfy the world's most demanding regulators.

VENDOR MANAGEMENT SERVICES

Your vendor ecosystem,
controlled and inspection-ready

Paulina and her team provide independent, objective oversight across your entire vendor landscape, from initial selection through ongoing performance, so you always know where risks sit before regulators do.

Advisory on Tools, Systems & Service Providers

We assess tools, systems, and service providers with the scrutiny regulators expect, asking the hard questions, checking the right evidence, and helping you select vendors who can truly deliver, so your choices are confident and defensible.

Vendor Oversight & Performance Tracking

We set up structured oversight, regular evaluations, clear Key Performance Indicators (KPIs), and documented monitoring, so you always know how vendors are performing and where to intervene, long before problems escalate.

Management and Oversight

We provide centralized governance and operational oversight across tools, systems, and service providers, defining accountability, monitoring performance, and coordinating activities so your vendor landscape stays aligned, transparent, and defensible.

Vendor Qualification & Audit Services

We perform independent qualification, audits, and gap assessments to verify capabilities, uncover risks, and confirm whether a provider is genuinely inspection-ready, so you can move forward with clarity, not assumption.

Clinical Trial Vendor Management

We provide structured oversight of clinical trial vendors supporting safety and related functions, managing qualification, performance monitoring, and compliance alignment so vendors operate consistently with protocols and regulatory expectations.

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Before you compare vendors or talk about outsourcing, you need to understand what great pharmacovigilance leadership really looks like. Dr. Henry Seto answers the question directly, and honestly. Press play to hear what most vendors won't tell you. ↓

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