Expertise That Powers Progress
Regulatory compliance, without the uncertainty
Expert consulting for biotechnology and pharmaceutical companies navigating TGA registration, GMP compliance and operational readiness in Australia including overseas companies entering the Australian market.
WHO WE HELP
Recognise any of these?
Yvonne Woo Consulting works with Biotechnology, Pharmaceutical and Medical Device companies at critical inflection points - new facilities, regulatory submissions and Australian market entry.
"We're opening a new facility and don't know where to start with GMP documentation."
- Operational Readiness support
"We're preparing for a TGA audit and need our QMS in order - fast."
- GMP compliance
"We're an overseas company wanting to register products in Australia."
- TGA product registration
"Our WHS documentation doesn't match what regulators expect."
- WHS Management System
CORE SERVICES
What we do
Tailored compliance and operational consulting - from a single document to full regulatory readiness programs.
GMP Compliance
End-to-end documentation and audit preparation aligned to TGA and PIC/S requirements.
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Site Master Files
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Contamination Control Strategies
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Cross-Contamination
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Quality Management Systems
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Policies
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SOPs & Work Instructions
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Facility & Process Risk Assessments
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Mock TGA audits & backroom support
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Materials & Incoming Goods documentation
Operational Readiness
Structured readiness programs for new facilities, Cleanrooms, Laboratories & Warehouses.
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Cleanroom, Laboratory & Warehouse readiness
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Manufacturing readiness
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Equipment & Material Management Frameworks
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Waste Management
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Pest Control & Environmental Management
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Staff training programs
TGA Product Registration
Provide end-to-end support for TGA product registration process from product assessment through to submission and ongoing compliance, helping overseas Manufacturers and Sponsors bring their products to the Australian market.
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Gap assessments
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TGA registration strategy & planning
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ARTG application preparation & submission
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Preparation & review of technical documentation (Chinese & English)
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Sponsor representation & regulatory liaison
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Medicines, medical devices and IVDs
Work Health and Safety
Provide tailored solutions to help businesses identify and manage workplace risks, achieve regulatory compliance and foster a strong safety culture.
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WHS Management System development & implementation
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WHS Policies & Procedures development
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WHS Risk Assessments
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Safe Work Method Statements
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Workplace inspections and safety audits
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Training and competency programs
PAST PROJECTS
Proven outcomes
A track record of high-stakes projects at Australia's leading Biomedical Institutes.
GLP Compliance
GLP-compliant laboratory - Translational Research Institute (2012)
Established a compliant laboratory during transition to commercial space: SOPs, WHS documentation framework and detailed risk assessments ensuring safe, compliant and efficient operations.
Operational Readiness
Brandl Street Facility & Cohort Laboratories - Southern RNA (2026)
Led the development of Contamination Control Strategies across two sites, established Cross-Contamination Control procedure, designed comprehensive Material Management Framework in collaboration with the Head of QA. Developed a Risk Assessment Framework and conducted facility and process risk assessments, strengthening GMP compliance and driving operational readiness.
Vaxxas Biomedical Facility (2023-2025)
Led documentation transfer, system establishment and training programs across Cleanrooms, Laboratories and Warehouse - ensuring GMP compliance and operational readiness.
TGA Licence
TGA Manufacturing Licence - Vaxxas Pty Ltd (2022-2025)
Partnered with QA team to build a comprehensive documentation framework through detailed process mapping, contributing to attainment of the TGA Manufacturing Licence.
Clinical Trials
Vaccine trials - Admedus Vaccines / Jingang Medicine Pty Ltd (2012-2020)
Under the direction of Prof. Ian Frazer, coordinated clinical trials across cross-functional teams, producing clinical data pivotal to Jingang Medicine's successful investor presentation and subsequent acquisition.
ABOUT
The person behind the work
Yvonne Woo Consulting combines deep technical expertise with practical, client-focused approach to deliver high-quality regulatory, quality and technical documentation. We support biotechnology, pharmaceutical and medical device companies by developing compliance documentation, optimising operational processes and providing tailored technical consulting that enhances efficiency and supports business growth.
Dr Yvonne Woo began her career as an Immunologist working alongside world-renowned experts in vaccine development and coordinating clinical trials for infectious diseases and cancer vaccines. She later transitioned into manufacturing and facility operations, where she held key leadership roles in Research, Compliance and Operational Readiness. Her experiences includes establishing documentation frameworks for new manufacturing facilities, driving continuous process improvements, implementing Operational Excellence initiatives and developing Work Health and Safety Management Systems.
With extensive research across research, manufacturing and regulatory compliance, Dr Woo delivers practical solutions that bridge scientific expertise with industry and regulatory requirements.
Dr Woo also provides multilingual consulting, documentation and translation services, supporting overseas manufacturers and international businesses entering or expanding within the Australian market.
Yvonne Woo, PhD.
Founder &
Global Technical, Quality & Compliance Strategist