Nicolas Huber

Who I am

With over 10 years of international pharmaceutical experience, I am a chemical engineer specialised in sterile manufacturing, Fill-Finish and Annex 1 implementation.

I have worked intensively with EU GMP Annex 1 from a practical, shop‑floor perspective, leading CAPEX projects in sterile manufacturing and Fill‑Finish for a multinational pharma company. In close collaboration with regulators and internal stakeholders.

I value speed, clarity and accountability, prefer working with high performers, and push projects forward with a practical, no‑nonsense approach that keeps scope, timelines and outcomes tightly aligned.

Why NAION exists

NAION was born from frustration with endless meetings and scope creep—we built a hands-on, high-performance team that delivers fast, focused results. Leveraging our Annex 1 expertise, European expert networks, and Fill-Finish suppliers, we boost Australia's life sciences sector with proven tech, lower risk, and smarter execution.

How NAION works

We start by listening: understanding what you need, where you are today and what is blocking progress.

From there, NAION acts as a practical bridge between European Fill‑Finish vendors, engineering partners and Australian life science teams, with a single point of contact on the ground who understands both regulatory expectations and day‑to‑day operations.

We focus on the critical path: Annex 1‑aligned GMP solutions, clear and stable requirements, and pragmatic implementation that protects timelines and budgets instead of complicating them.