Hi, I’m Kathryn, Quality Manager at Biofortuna. Here, Quality is more than a requirement – it is the foundation of everything we do.

As a life sciences CDMO, we support organisations across development, manufacturing, quality control and storage – all within one robust Quality Management System.

Every project, every sample and every customer receive the same high standards of care, compliance and scientific excellence. Because consistency is what protects quality

Our quality framework

Our quality framework is built around internationally recognised accreditations and regulatory approvals. These demonstrate the strength of our systems and the trust placed in us across medical, diagnostic and research environments.

We are ISO 13485 certified for medical device quality management. This builds on ISO 9001, ensuring our systems meet the rigorous demands of regulated healthcare and diagnostic environments.

We also operate to ISO 17025 standards, demonstrating technical competence, validated methods and reliable laboratory testing for confidence in every result we produce

Data integrity and traceability are also embedded into our operations.

Through controlled documentation, secure data management and validated workflows, we ensure every data point is accurate, consistent and fully traceable throughout its lifecycle.

Quality goes beyond accreditation alone

We operate validated methods supported by continuous monitoring and routine review.

Across our laboratory and facilities, carefully controlled environments and processes help ensure consistency, reliability and confidence at every stage.

This attention to detail helps us maintain the high standards our customer depend on every day.

But quality isn’t just about compliance, it’s also about service.

Our dedicated Customer Engagement Managers and project teams work closely with every customer, providing expert guidance and clear communication from initial enquiry through to delivery.

They act as the link between your team and our laboratory operations, helping ensure timelines, technical requirements and expectations are manged efficiently and transparently.

Quality you can trust at every stage

At Biofortuna, quality is not simply a process.

It’s a culture built on continuous improvement, scientific integrity and trusted partnership.

Because when quality matters, every detail matters.

To learn more about us, our dedication to excellence and our quality framework, contact us today.

A culture of quality, a partner you can trust