The radiopharmaceutical theranostics field is growing at an unprecedented pace. Scientific breakthroughs are accelerating, and the engineering of new manufacturing plants is in full swing. We see regular announcements of new tracers, new therapies, and new facilities being planned or built. The focus is intense — and rightly so — on the technical and scientific challenges of this exciting field.
But as Byron Fitzgerald aptly asked in his recent post: Who will run these facilities?
It’s a question that deserves more attention.
While the science and engineering are critical, they are only part of the equation. Once the CAPEX is spent and the facility is built, the real work begins: producing reliably, compliantly, and cost-effectively — day after day. This requires more than machines and molecules. It requires people, systems, and culture.
At Qualificiency Consulting, this is where our passion lies.
We’ve seen too often that operational readiness is underestimated. Staffing plans are minimum. Skills are assumed. Quality systems are incomplete. Maintenance is reactive. Distribution routes are unclear. Sales, production, and delivery are not aligned. Accessories and consumables are forgotten until the last minute.
And then the scramble begins.
Our experience tells us that these challenges are not inevitable. They are preventable — if addressed early. That’s why we advocate for integrating operational, quality, and organizational thinking from the very start of any radiopharma project. Not as an afterthought, but as a core pillar of success.
Because in the end, it’s not just about building a facility. It’s about running it — safely, compliantly, and sustainably. It’s about enabling the brilliant science and engineering to come to life, every single day.
If you're planning a new radiopharma facility or scaling an existing one, let’s talk. We’d love to share our insights and help you build not just a plant, but a thriving operation.
👉 Visit www.radiopharma-consulting.com to learn more.