About OZQA
At OZQA, we believe that building and maintaining a compliant Quality Management System should not be unnecessarily complex, time consuming or expensive. We help pharmaceutical, biotechnology, medical device and other regulated organisations establish, improve and digitalise their QMS through ready to implement documentation, practical Quality solutions and expert support.
WHY WE FOUNDED OZQA
Quality should enable progress, not slow it down.
Traditional QMS implementation often involves lengthy consulting projects, extensive documentation development and significant investments before a system becomes operational. We saw an opportunity to do things differently.
OZQA was founded to make professional Quality Management more accessible by providing structured, ready to implement QMS solutions that reduce the time, cost and complexity of establishing compliant Quality processes.
Instead of starting from scratch, our customers can build on an established framework and adapt it to their organisation, activities and regulatory responsibilities.
THE PEOPLE BEHIND
Meet the OZQA team
Get to know the people behind OZQA. Each person brings deep expertise and a shared commitment to delivering practical, compliant solutions for your pharmaceutical or medtech company. OZQA combines deep subject-matter expertise with structured, ready-to-use documentation and targeted consulting support, helping companies meet regulatory requirements efficiently and with confidence.
FOUNDER
Hasse Herlevsen
Founder of OZQA and the company’s principal expert within pharmaceutical quality and GxP compliance.
He brings more than 30 years of experience from the pharmaceutical and biotech industry and has held senior leadership positions, including Vice President for Global Quality & EHS at Leo Pharma. Hasse has been involved in more than 50 regulatory inspections and has led global quality organisations across multiple countries and regulatory frameworks.
At OZQA, Hasse ensures that all pharmaceutical solutions are aligned with real-world inspection expectations, regulatory requirements, and best practices in GxP-regulated environments.
FOUNDER
Helena Christensen
Founder of OZQA and works hands-on with QMS for both pharmaceutical and medical device companies.
She has experience supporting organisations operating under GxP requirements as well as ISO 9001 and ISO 13485, with a strong focus on building clear, usable, and inspection-ready QMS structures. Helena works closely with clients to ensure that quality systems are aligned with regulatory expectations while remaining practical and proportionate to the organisation.
At OZQA, Helena is involved in QMS design, SOP structures, documentation frameworks, and overall quality system alignment across pharma and medtech.
PARTNER
Louise Søgaard Nielsen
Senior Pharmacovigilance consultant with more than 20 years of experience across EU Pharmacovigilance activities.
She has extensive hands-on expertise in EU GVP-compliant PV systems, including QPPV support, PSMF management, PV SOPs, PV agreements, and PV audits. Louise has supported companies both before and after marketing authorisation and has significant experience implementing scalable PV systems for emerging biotech companies.
At OZQA, Louise supports clients with Pharmacovigilance system setup, compliance oversight, audit readiness, and ongoing PV advisory services.
WHAT MAKES OZQA DIFFERENT?
Making quality management simple, accessible and scalable.
Our QMS packages include structured SOPs, supporting forms and practical guidance designed to accelerate implementation. From early pharmaceutical development to clinical trials, commercial operations and medical device lifecycle management, our solutions are designed around the Quality requirements relevant to your activities. Start with the processes you need today and expand your QMS as your organisation, operations and regulatory responsibilities evolve.
Our services are supported by experienced Quality and regulatory professionals who can assist with implementation, training, improvement, digitalisation and ongoing Quality activities.
Our Mission
To make effective Quality Management accessible to organisations of all sizes through practical, scalable and cost efficient solutions. We aim to reduce unnecessary complexity while helping organisations establish Quality systems that work in everyday operations, not just on paper.
Our Vision
A future where every organisation can access a professional, reliable and scalable Quality Management System without the traditional barriers of time, cost and complexity.
START WHERE YOU ARE
Three ways to build a better QMS.
The OZQA QMS provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.
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