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GVP Audit Readiness You Can Trust, and the Person Behind It

Lucia Matejkinova leads our GVP audit readiness practice. A certified PV auditor (RQA, GVP and ISO 19011) who has served as EU and UK QPPV and run both internal and third-party audits, she knows what readiness looks like because she's spent her career on both sides of the audit.

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

GVP AUDIT READINESS

Your PV quality system, built to
hold up under scrutiny.

Most quality frameworks look fine on paper. Lucia and her team make sure yours holds up in practice, with Standard Operating Procedures (SOPs) your teams can actually follow, documentation that reflects how your system really works, and oversight that catches gaps before regulators do.

Standard Operating Procedures (SOP)

We develop and maintain clear, compliant Standard Operating Procedures (SOPs) that support your Pharmacovigilance (PV) system across clinical development, marketing application, and post-authorization. SOPs are tailored to your company's size and structure, reflect outsourced activities, and align with applicable Good Pharmacovigilance Practices (GVP) requirements, so your documentation is inspection-ready and defensible.

Audits & Inspection Support

We help you understand where you stand, prepare the right evidence, and address gaps before they become findings, across marketing application and post-authorization PV systems. When issues arise, we guide you through Corrective and Preventive Actions (CAPAs) with clarity and confidence, so nothing is left unresolved.

Pharmacovigilance System Master File (PSMF)

We create and maintain a Pharmacovigilance System Master File (PSMF) that accurately represents your organization across marketing application and post-authorization PV systems. It stays up to date, aligns with regulatory expectations, and truly reflects how your PV system operates, so you always know it's inspection-ready.

Quality Oversight

We provide continuous quality oversight across clinical development, marketing application, and post-authorization activities, covering partners, processes, data flows, and documentation, giving you visibility, control, and peace of mind across your entire PV system.

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