About OZQA

OZQA is a quality and compliance advisory focused on practical, inspection-ready QA and PV solutions for pharmaceutical and medical device companies.

Two ways to work with us

OZQA offers flexible solutions that grow with your organization

From ready-to-use SOP templates to full QMS implementation or pharmacovigilance activities, you can choose the level of support that fits your stage and structure.

Pre-filled, audit-ready SOPs and log forms

Implementation and consultancy work

Templates

Consulting

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.

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Consultant - Pharmacovigilance

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.

Is your QMS inspection-ready?

We’ll show you how OZQA’s solution can save you time and give you complete peace of mind before your next audit.

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