GMP · ISO 13485 · 21 CFR PART 210/211 · ICH
Partnering with you to build quality that works.
Just Quality Consultancy delivers expert quality and regulatory guidance to the pharmaceutical, medical device, biotechnology, and dietary supplement industries across New Zealand, Australia, and international markets.
Who we work with
We support pharmaceutical, medical device, biotechnology, and dietary supplement manufacturers across New Zealand, Australia, and international markets — from producers scaling up to established enterprises refining mature systems. Our experience spans regulatory frameworks including MedSafe, ACVM and MPI (NZ), TGA and APVMA (Australia), FDA (USA), EMA (Europe), and MHRA/VMD (UK), alongside GMP, MPI RMP, ISO 13485, and ISO 22716.
Expertise
Quality Management Systems
Design, implementation, and optimisation of QMS frameworks, including QMS KPIs.
Regulatory Compliance & Audit Management
Preparation, hosting, and response for regulatory and client audits.
Training & Quality Culture
GMP training, programme development, and building quality as a genuine business partner.
Validation & Continuous Quality Improvement
Equipment, process, and software validation, with Lean Six Sigma–informed improvement.
Why Just Quality
20+ years of industry experience
Including senior leadership roles at contract manufacturing organisations and multi-nationals, across Quality Control, Quality Systems, and Quality Assurance.
Deep regulatory knowledge
Direct experience across NZ, Australian, US, European, and UK regulatory bodies and standards — GMP, ISO 13485, 21 CFR Part 210 / Part 211, ICH, and more.
Practical, not theoretical
Systems built to be run day-to-day by your team, not just when there's an audit.
A partner, not a one-off auditor
We work alongside you through implementation and continuous improvement, not just at the inspection stage.
Ready to strengthen your quality systems?
Whether you need a single gap analysis or ongoing quality management support, we'll start with a conversation about where you are now.