Experience behind
Bridging Engineering & Compliance
Nicolas Huber is a pharmaceutical engineer and leader from Switzerland with deep hands‑on experience in sterile filtration, aseptic processing, EU GMP Annex 1 and CAPEX project delivery in regulated biopharmaceutical environments.
This includes the design and implementation of PUPSIT concepts, sterile filtration modernization, line integrity strategies, authority-facing EU GMP Annex 1 topics and the introduction of single-use technologies to strengthen sterility assurance.
Over several years, this work has been carried out together with leading European sterile and aseptic process experts to strengthen process robustness and always-on inspection readiness.
Member & Author of the Parenteral Drug Association (PDA).
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
End-to-end project & program management from technical concept through implementation and qualification, with a single point of contact.
Aseptic Process Improvement
Strengthen contamination control strategies and aseptic processes, making operations more efficient and robust with a focus on practical risk reduction and operational improvement.
European Technical Network
Access to selected European experts and practical quality-critical manufacturing know-how for faster implementation and more cost-effective projects.
Why
European GMP Annex 1 experience.
Get audit proven solutions from European experts.
Direct European access.
Strong network across European fill-finish specialists.
Local availability.
Based in Melbourne with local availability.
By your side when it matters.
Support during customer audits and authority inspections.
European GMP Annex 1 experience.
NAON combines proven European implementation excellence with deep expertise in the EU GMP Annex 1.
Previous Projects
PUPSIT implementation
Design and implementation of Annex 1 – compliant PUPSIT strategy in a legacy facility, from feasibility to qualification and authorities inspection.
Sterile Filtration Integrity
Development and optimization of sterile filtration concepts, including single-use systems, integrity test strategies, and lifecycle documentation for global sterile drug manufacturers.
Hygiene Concept & CCS
Support and upgrade of contamination control strategies and hygiene concepts, linking facility design, cleaning and disinfection and gowning to a coherent CCS framework.
Process Optimization
Support for global pharma sites to troubleshoot and optimize aseptic processes and address inspection findings without compromising sterility assurance.