ABOUT
EXPERIENCE
Our expertise spans over a decade of delivering GMP compliance and validation services across global regulated industries.
We have supported projects ranging from small-scale biotech startups to large pharmaceutical manufacturing facilities, ensuring full compliance with international regulatory expectations.
Our approach focuses on risk-based validation strategies, operational efficiency, and inspection readiness at every stage of the project lifecycle. I
GMPliance has supported projects and operations across globally recognised pharmaceutical and biotechnology organisations, contributing to compliance, validation, quality assurance, and operational excellence initiatives within highly regulated environments.
Industry exposure includes experience across multinational organisations and manufacturing environments associated with:
• Johnson & Johnson
• GSK
• Pfizer
• AstraZeneca
• Hamilton
• Roche
• Novartis
• Tecan
This broad industry exposure provides GMPliance with practical insight into global regulatory expectations, quality culture, and large-scale GMP operations across diverse therapeutic and manufacturing areas.
MISSION
Our mission is to support organisations in achieving and maintaining the highest standards of GMP compliance through practical, science-based and risk-driven solutions.
We aim to simplify complex regulatory requirements and translate them into effective quality systems that work in real-world environments.
• Validation & Qualification (Facilities, Equipment, Systems)
• Quality Assurance & GMP Compliance (FDA, EMA, TGA, MHRA)
• GxP Facility Design & Project Delivery
• Quality System Improvement & Inspection Readiness
• CAPA, Change Control & Deviation Management
SERVICES
GMP Validation & Qualification Services
We provide end-to-end validation support for facilities, equipment, utilities, and computer systems using risk-based approaches aligned with global regulatory expectations.
GMP Audit & Compliance Services
We conduct gap assessments, internal audits, and inspection readiness reviews to ensure compliance with FDA, EMA, MHRA, PIC/S, ISO 13485, and ISO 9001 standards.
Quality Management Systems (QMS/eQMS)
We support implementation and optimisation of quality systems including CAPA, deviations, change control, and supplier quality management to ensure regulatory robustness and efficiency.
Facility & Cleanroom Design Support
We assist in the design and qualification of GMP-compliant facilities and cleanrooms, ensuring compliance from concept through to operational readiness.
Technical Documentation & Regulatory Support
We develop and review validation protocols, SOPs, risk assessments, and regulatory documentation required for inspections and submissions.
Recent Updates
- Validation & Qualification Update | Australia – Moving Beyond Template-Based Compliance
- GMP & TGA Update | Increased Focus on Data Integrity and System Validation
- Why Adopting TGA Makes Freeze Dryer Qualification a Breeze
- ⚙️ Equipment Maintenance: The Unsung Hero of Your Workday
- How to Qualify Cleanrooms in Australia (Without Falling Asleep Doing It)
- The Future of GMP Compliance: Are You Ready for 2026?
- Validation in 2026: It’s No Longer a Checkbox — It’s Your Competitive Edge
- Is Your CAPA System Audit-Ready in 2026? Most Aren’tIs Your CAPA System Audit-Ready in 2026? Most Aren’t
- 🇦🇺 How Is GMP Manufacturing Done in Australia — and How Does It Compare to the US and EU?
WHY GMPliance?
• Deep regulatory knowledge across global agencies
• Risk-based and science-driven methodologies
• Practical implementation in real manufacturing environments
• Focus on long-term compliance sustainability