Consulting
OZQA provides QA and PV consulting support within quality management, regulatory compliance, and pharmacovigilance for pharmaceutical and medical device companies.
Quality Assurance & Pharmacovigilance Support
Our QA and PV consulting services complement our SOP templates and QMS documentation, offering flexible, hands-on expertise where additional support is required. We focus on inspection-ready solutions, proportionate quality systems, and clear regulatory alignment.
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Consulting support is provided without long-term commitments and tailored to the specific needs, maturity, and regulatory context of each organisation.
Areas of Consulting Support
Quality Assurance (QA)
We support pharmaceutical, biotech, and medical device companies with the establishment, maintenance, and improvement of compliant Quality Management Systems.
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Our Quality Assurance consulting covers:
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GxP compliance (GMP and GDP)
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ISO 9001 and ISO 13485 quality systems
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QMS structure and implementation
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SOP development and process documentation
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Deviation, CAPA, Change Control, and OOS processes
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Audit and inspection preparation
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Oversight of outsourced partners
Support is practical, documentation-focused, and aligned with regulatory and certification expectations.
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Pharmacovigilance (PV)
We provide structured consulting support within EU Pharmacovigilance for companies before and after marketing authorisation.
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Our Pharmacovigilance consulting includes:
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EU GVP-compliant PV system setup and maintenance
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QPPV support and back-up arrangements
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PSMF development and review
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PV SOPs and agreements
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PV audits and inspection readiness
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Ongoing PV advisory support
All services are aligned with EU GVP requirements and designed to support both emerging biotech companies and established MAHs.
How We Work
OZQA consulting is intended to support specific quality and compliance needs, not to replace internal ownership of QA or PV systems:
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Flexible consulting without long-term commitments
Clear scope and transparent hourly billing
Support tailored to company size, maturity, and regulatory setup
Focus on documentation quality and regulatory compliance
Practical solutions grounded in real inspection experience
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