Bridging European Annex 1 Expertise
with Australia’s Life Sciences Industry
NAON is a Melbourne-based engineering firm specialized in EU GMP Annex 1 for sterile manufacturing and aseptic processing, supporting Australian pharma and biotech manufacturers with compliance and direct access to European experts and technology partners.
Our Services
Annex 1 Assessments & Audits
Targeted Annex 1 assessments to identify compliance, technical and operational gaps in sterile manufacturing and define remediation actions.
Project Management, Implementation & Qualification
End-to-end project management from technical concept through implementation and qualification, with a single point of contact.
Aseptic Process &
CCS Improvement
strengthen contamination control strategies and aseptic processes, with a focus on practical risk reduction and operational improvement.
European Technical Network
Access to selected European experts and practical sterile manufacturing know-how for Annex 1 implementation and sterile project delivery in Australia.
Why
Clarity in a complex World.
European GMP Annex 1 experience.
NAON combines proven European implementation excellence with deep expertise in the EU GMP Annex 1.
Direct European access.
Strong network across European automation, RABS, isolators, and fill-finish specialists.
Independent advice.
Zero equipment ties, zero sales commissions. Solutions based on YOUR process and budget.
By your side when it matters.
From preparation to the audit, NAON supports your team on-site to defend decisions and explain risks.
Events
About us
NAON was founded on a simple principle: turning vision into action without unnecessary complexity.
Our focus: helping biotech and pharma teams advance Annex 1 compliance and sterile operations with patient safety at the core.
Ready to partner with teams who want tangible results and lasting impact.
Let’s talk.