Quality & Compliance
for Regulated Industires
OZQA delivers practical QA and PV solutions for biotech, pharma and medtech companies, including SOPs, implementation support, and expert guidance to ensure full GxP compliance.
Inspection-ready quality systems and pharmacovigilance support for pharma and medtech. SOP templates, consulting, and QMS expertise covering GxP, ISO 9001, ISO 13485, and EU GVP.
QA/PV Templates & consulting
OZQA provides Quality Assurance (QA) and Pharmacovigilance (PV) documentation, practical consulting, and real inspection experience for companies operating in regulated environments.
Document Templates
Professionally written, pre-filled SOP templates and log forms designed to support compliant Quality Management Systems.
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GxP SOPs for pharmaceutical companies
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ISO-based documentation for medical devices
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Log forms and registers supporting traceability and inspections
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Audit-tested, inspection-ready structure
Consulting Support
Flexible consulting support within quality management, regulatory compliance, and pharmacovigilance (QA and PV) for pharmaceutical and medical device companies provided on an hourly basis.
Pharmaceutical quality systems (GxP)
Medical device quality systems (ISO 9001 & ISO 13485)
Pharmacovigilance (EU GVP)
Audit preparation and inspection support
Pre-filled Document Templates
The SOP templates are designed for companies that need structure without bureaucracy, compliance without chaos, and documentation that truly works in daily use. Whether you’re running clinical trials, outsourcing manufacturing, or scaling your quality function, OZQA helps you achieve inspection readiness with confidence.
We help you meet EMA, FDA, and ICH GxP requirements faster and more efficiently.
Why Clients Choose Us
Time-saving
A complete system implemented within weeks.
Regulatory assurance
Developed according to current regulatory standards.
Scalable
Designed to grow with your organization.
Inspection-ready
Meets authority requirements from day one.
QA & PV Support
Our Quality Assurance and Pharmacovigilance 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.
Consulting support is provided without long-term commitments and tailored to the specific needs, maturity, and regulatory context of each organisation.
