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In the early stages of development, many small biotech companies are focused on advancing their science, securing funding, and reaching key clinical or regulatory milestones. Quality systems often develop gradually alongside these priorities. However, as programs move closer to regulatory submissions or clinical trial expansion, they inevitably face a critical question: is the quality system […]

Working in GxP environments has changed my approach to project management. One of the biggest lessons was discipline. In GxP, structure is not optional. Processes, approvals, and reviews exist for a reason, and I learned that clear plans and documented decisions don’t slow projects down. They make them run better. Documentation was another mindset shift.

This statutory instrument amends the Medicines for Human Use (Clinical Trials) Regulations 2004 (2004 No.1031). The legislation aims to protect public health and trial participants while supporting the development of new and improved medicines. It seeks to remove barriers to innovation through proportionate, risk-based approaches; to streamline clinical trial processes and maintain strong oversight of

When people think about patient safety in clinical and regulated environments, they often picture clinicians, investigators, or auditors. These roles are rightly visible and critical. What is less visible is the influence of Project Management on patient safety long before any direct interaction takes place. As a Project Manager, I do not work with patients

The medical device landscape is evolving fast driven by innovation, digital technologies, and tighter global regulations. At the center of this change sits ISO 13485, the foundation for quality management in the medical device industry. While ISO 13485:2016 remains the current benchmark, its future direction is becoming increasingly clear. One major shift is global regulatory

It’s a new year. I wish you a rewarding and joyful 2026. At this fairly arbitrary point in our journey round the sun, we habitually resolve to renew and redouble our efforts at work and on self-improvement. In this context, and in the equally arbitrary annual performance review cycle at work, we are often encouraged

As we progress further into the new year, I’ve been taking time to reflect on what I want to carry forward as a Project Coordinator, including new skills I have acquired and key lessons I have learned along the way. A few key things to remember: Leadership Clear objectives, a defined scope, and aligned expectations are key to managing a successful project. ensuring we are asking the

For over a century, medical devices carried a name that implied neutrality: tools, instruments, machines. Device – from Latin dispositus – arranged, structured, prepared. The word suggested passive utility. A scalpel did not question. A monitor did not judge. A pacemaker simply pulsed. In the regulated world, quality assurance reinforced that neutrality: devices were checked,

Since the implementation of Medical Device Regulation (EU) 2017/745, audits across medical device manufacturers, distributors, and service providers continue to reveal recurring compliance challenges. These issues are rarely isolated failures; rather, they reflect systemic gaps in governance, documentation, and regulatory integration. The following pitfalls represent common themes observed during MDR-focused GMP and quality system audits

The Financial Integrity Behind Every Audit: Budget Management as Quality Assurance Quality consulting isn’t just about technical excellence—it’s about delivering that excellence within agreed commercial parameters. As a Project Administrator at RiverArk Limited, budget management is one of my most important responsibilities. Not because we’re focused on cutting corners, but because financial discipline is itself