Compliance that
holds up under
audit.
We build ISO 9001, GMP, HACCP and TGA-ready quality systems that regulators accept and operators actually use — designed around how your business already runs.
- ISO 9001
- GMP
- ISO 22716
- HACCP
- TGA
Quality, compliance and regulatory services
Quality management systems
Certified quality management systems, streamlined with continuous improvement built in.
02Pharmaceutical GMP
Support from gap assessment through to a TGA GMP manufacturing licence and audit.
03Cosmetics GMP (ISO 22716)
ISO 22716 Cosmetics GMP certification support and third-party GMP audits.
04Medical devices (ISO 13485)
Medical device registration and ISO 13485 quality management systems.
05HACCP food safety
HACCP food hygiene programs, from gap assessment to certification audit.
06SEDEX support
Preparation for SMETA audits and SEDEX-based supply chain and ESG requirements.
Quality systems designed around the way your business works.
Meeting a regulatory requirement and running a workable business are the same problem, not two. We design quality systems that satisfy the standard and still fit the way work actually moves through your site — so procedures are used rather than filed.
Practical systems
Documentation written for the people who use it, sized to the business rather than the standard's page count.
Audit readiness
Evidence, records and responsibilities in place before an inspection is scheduled, not after it is announced.
Continuous improvement
The same system used for compliance becomes the one you use to find waste and lift performance.
Courses that build capability inside your team.
ISO 9001 Awareness Training
An introduction to the quality management standard — what it asks for, and what an auditor looks for in everyday practice. View course →
Internal Audit Training
Plan, run and report internal audits against ISO 19011 so they surface real findings rather than paperwork. View course →
ISO 22716 Cosmetic GMP Training
The key good manufacturing practice requirements for cosmetic production, packing and in-process control. View course →
Operations Strategic Review (OSR)
Value-stream mapping and the seven wastes, applied to connect operations work to throughput, lead time and cost. View course →
Pharmaceutical GMP
GMP for pharmaceutical manufacture — documentation, cleaning and sanitisation, and the quality system behind PIC/S and TGA expectations. View course →
Quality Risk Assessment Training
Risk assessment as a preventive tool — FMEA and hazard analysis in line with ICH Q9, ready to apply to real decisions. View course →Every course is delivered online, so a team can be trained without pulling everyone into the same room on the same day.
Regulated industries, understood from the inside.
Work spans health products, food and general manufacturing, including businesses that import or wholesale rather than manufacture.
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Pharmaceutical
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Medical devices
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Cosmetics
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Food
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Laboratories
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Importers & wholesalers
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Manufacturing
Experienced guidance when the details matter.
Consulting is led by Kok Yin Loke, Principal Consultant, working directly with your team rather than at a distance.
Preparing for an audit, certification or regulatory inspection?
Start with a conversation about where your business is today and what needs to happen next.
Book a consultationSuite 064, 44 Lakeview Drive
Scoresby VIC 3179