Why OZQA Was Created: Simplifying Quality Systems in Life Science

OZQA was founded with a clear ambition: to help life science companies build practical and effective quality systems without unnecessary complexity.

After more than three decades in the pharmaceutical and biotech industry, including senior leadership roles in global quality organisations, Hasse Herlevsen saw first-hand how quality systems were often implemented in ways that made them difficult to operate for smaller and growing companies.

OZQA was therefore established to provide a more pragmatic approach to quality and compliance.

Experience from Global Pharmaceutical Quality

Before founding OZQA, Hasse Herlevsen spent over 30 years working in the pharmaceutical industry, including nine years as Vice President for Global Quality & EHS at LEO Pharma.

During this time, he worked extensively with:

• Global quality management systems

• Regulatory inspections and audits

• Quality governance in international pharmaceutical organisations

• Compliance frameworks across highly regulated markets

This experience provided deep insight into how quality systems function in large pharmaceutical organisations and where they often become unnecessarily complex.

A Different Approach to Quality Systems

Many life science startups and biotech companies adopt quality systems originally designed for large pharmaceutical organisations.

While these frameworks may be robust, they can also introduce significant administrative burden and slow down innovation.

OZQA was founded on the principle that quality systems should be:

• Compliant with regulatory expectations

• Proportionate to the organisation’s size and activities

• Practical and easy to maintain

The goal is to help companies build structured systems that support compliance while allowing teams to focus on science and development.

Supporting the European Life Science Ecosystem

Today, OZQA supports pharmaceutical, biotech and medical device companies with activities including:

• Quality management systems (QMS)

• EU pharmacovigilance compliance

• SOP development and documentation

• Audit and inspection preparation

The company works with organisations ranging from early-stage biotech companies to more established life science organisations preparing for regulatory milestones.

Looking Ahead

The life science sector continues to evolve rapidly, particularly in Europe where biotech innovation is accelerating.

As regulatory expectations grow, the need for clear, scalable and practical quality systems becomes increasingly important.

Through OZQA, Hasse Herlevsen aims to contribute to a life science environment where quality and innovation support each other rather than compete.