EU Quality infrastructure. Built before you need it.

Virtual Quality Partners is the subscription-based EU/EEA quality partner for virtual and emerging biotech.

We provide QP, RP, and MAH services from clinical stage through commercial launch.

Fixed scope. Fixed cost. Inspection-ready from day one.

Who we serve

Built for virtual and emerging biotech. Scaled to your stage.

VirtualQP works with organisations that need senior-level EU quality infrastructure without the overhead of building it internally.

  • Approaching your first MAA submission and need a PQS that will withstand PAI scrutiny. We build your quality infrastructure in parallel with your regulatory timeline — so approval and inspection readiness arrive together.

  • Operating without a dedicated QA function. We act as your outsourced quality department — QP, RP, and MAH services under a single subscription, with full accountability and regulatory standing.

  • Japanese, Korean, Taiwanese, or Gulf-region companies navigating EU market entry for the first time. We provide an end-to-end EU Gateway package — MAH establishment, RP/QP appointment, GDP-compliant logistics setup, and regulatory filing support — with direct experience of PMDA and MHLW inspection frameworks.

  • Already on the market but carrying quality infrastructure risk. We provide ongoing QP/RP oversight, GDP compliance, and HPRA readiness as a managed service — so your commercial operations remain audit-ready year-round.

Core Services

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“The only subscription-based quality infrastructure model in EU pharma”

Fixed monthly scope. No retainer surprises. No invoice ambiguity. Designed for CFOs and quality leaders managing lean budgets across clinical and commercial programmes.

Why Virtual QP?

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Our Edge

The only Irish-based quality firm with direct PMDA and MHLW inspection experience.

For Japanese, Korean, Taiwanese, and Gulf-region biotech entering the EU market, we don't just know the EU regulatory framework — we already speak your regulatory language.

APAC/MENA Inspection Experts

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Built for Clinical Stage

Inspection-ready 18 months before your MAA submission.

Our pre-approval programme builds your full PQS from the ground up — structured for PAI readiness, aligned to HPRA expectations, and designed so your first regulatory inspection is never your first test.

Pre-Approval Programme

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Our Leadership Team

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  • Dr. Fitzgerald brings over 25 years of experience in the pharmaceutical industry, with a strong background in Technical Operations across the product lifecycle. For the past 15+ years, he has served as Head of Quality for organizations holding Clinical (IMPD/IND) and Commercial (MA/NDA/BLA) product authorizations. He is an active contract Responsible Person (RP) ensuring robust regulatory compliance and operational oversight and has hosted multiple Regulatory inspections (HPRA PAI WDA/MIA/MIA IMP, MHLW/PMDA MA) over the past 10+ years with no major findings.

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  • Padraig Long has over 18 years of experience in the pharmaceutical industry, specializing in Quality Operations across both small and large molecule programs. He is an experienced Qualified Person (QP) for companies holding Clinical (IMPD/IND) and Commercial (MA/NDA/BLA) authorizations, with responsibility for batch certification and ensuring full compliance with the terms of each company’s Manufacturing and Importation Authorisation (MIA).