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In the complex world of life sciences, quality consulting firms often promise expertise and support. Yet, many fall short when it comes to delivering practical, comprehensive solutions that truly help companies grow. At OZQA, we believe we are different. Our CEO, Helena Christensen, shares why our approach, network, and services set us apart from other quality consulting firms. OZQA's integrated approach to quality management in life sciences Building a Network of Specialists

OZQA is featured in Science Report highlighting how lack of competencies, not regulation, is slowing the life science industry. Learn how to

OZQA invites life science consultants and regulatory experts to collaborate on quality systems, pharmacovigilance and compliance projects.

Louise Søgaard Nielsen joins OZQA as pharmacovigilance consultant, strengthening EU pharmacovigilance and GVP compliance support for biotech

OZQA expands consulting support for medical device companies with ISO 13485 quality systems, SOP development and notified body audit prepara

OZQA, a European quality and compliance advisory for life science companies, has launched a new online webshop offering ready-to-use SOPs, log templates and regulatory documentation designed specifically for biotech companies outsourcing clinical studies. The webshop provides practical documentation packages that help companies establish or strengthen their quality systems and pharmacovigilance processes while working with external clinical research organisations (CROs). Biot

Learn why Hasse Herlevsen founded OZQA to help biotech, pharma and MedTech companies build practical quality and compliance systems.

For companies marketing medicines in the European Union, the Pharmacovigilance System Master File (PSMF) is a core regulatory requirement. The document provides regulators with a detailed overview of the pharmacovigilance system used by the marketing authorisation holder (MAH). Despite being mandatory, many companies struggle with how to structure the PSMF and how detailed it needs to be. This article explains the purpose of the PSMF, its regulatory background, and how compan

For pharmaceutical and biotech companies entering or operating in the European market, pharmacovigilance (PV) is a critical regulatory requirement. A well-structured pharmacovigilance system ensures that the safety of medicinal products is continuously monitored once they are on the market. However, many companies especially startups or companies new to Europe are unsure how extensive their PV obligations are and how to implement them efficiently. This article provides an ove

In a time when biotech and medtech are moving faster than ever, one thing has barely changed in the last 20 years: documentation. SOPs, procedures, templates, and log forms form a foundation that should ensure consistency and compliance. But in many companies, it has instead become a bottleneck that slows progress and drains resources. An Invisible Bottleneck No One Talks About Ask startup founders and QA professionals behind closed doors, and the message is the same: Documen

In a time when biotech and medtech are moving faster than ever, one thing has barely changed in the last 20 years: documentation. SOPs, procedures, templates, and log forms form a foundation that should ensure consistency and compliance. But in many companies, it has instead become a bottleneck that slows progress and drains resources. An Invisible Bottleneck No One Talks About Ask startup founders and QA professionals behind closed doors, and the message is the same: Documen

In a time when biotech and medtech are moving faster than ever, one thing has barely changed in the last 20 years: documentation. SOPs, procedures, templates, and log forms form a foundation that should ensure consistency and compliance. But in many companies, it has instead become a bottleneck that slows progress and drains resources. An Invisible Bottleneck No One Talks About Ask startup founders and QA professionals behind closed doors, and the message is the same: Documen

In a time when biotech and medtech are moving faster than ever, one thing has barely changed in the last 20 years: documentation. SOPs, procedures, templates, and log forms form a foundation that should ensure consistency and compliance. But in many companies, it has instead become a bottleneck that slows progress and drains resources. An Invisible Bottleneck No One Talks About Ask startup founders and QA professionals behind closed doors, and the message is the same: Documen

I en era där bioteknik och medicinsk teknik utvecklas snabbare än någonsin tidigare finns det en sak som knappt har förändrats under de senaste 20 åren: dokumentation. Standardrutiner, procedurinstruktioner, mallar och protokollformulär utgör grunden som säkerställer konsekvens och efterlevnad av regelverk. Men i många företag har det blivit en flaskhals som hämmar framstegen och förbrukar resurser. En osynlig flaskhals som ingen pratar om. Om du frågar startupgrundare och...

In a time when biotech and medtech are moving faster than ever, one thing has barely changed in the last 20 years: documentation. SOPs, procedures, templates, and log forms form a foundation that should ensure consistency and compliance. But in many companies, it has instead become a bottleneck that slows progress and drains resources. An Invisible Bottleneck No One Talks About Ask startup founders and QA professionals behind closed doors, and the message is the same: Documen

Learn how to implement a Quality Management System without bureaucracy. A step-by-step guide for biotech and life science companies using te

Learn how to implement a Quality Management System without bureaucracy. A step-by-step guide for biotech and life science companies using te

Learn how to implement a Quality Management System without bureaucracy. A step-by-step guide for biotech and life science companies using te

Learn how to implement a Quality Management System without bureaucracy. A step-by-step guide for biotech and life science companies using te

Learn how to implement a Quality Management System without bureaucracy. A step-by-step guide for biotech and life science companies using te