Our highly experienced Quality and Compliance team brings in-depth expertise in building and maintaining systems that align with GMP and regulatory expectations in Australia and New Zealand.
Your Partner in Quality and Compliance
We help ensure your products consistently meet quality standards by developing robust quality systems, supporting ongoing compliance activities, and providing supply-related quality guidance.
Our consultants can work as an extension of your team – whether closely collaborating with your local or global stakeholders, or operating independently to deliver results with minimal oversight. We offer flexible support tailored to your needs: from acting as your local QA Manager to simply stepping in to fill specific resourcing or capability gaps.
We support continuous quality oversight across all aspects of your operations, including managing product quality complaints, investigating deviations, supporting risk mitigation strategies, and ensuring regulatory compliance.
In addition, we can provide expert support across the supply chain – from licence and permit applications to batch release, recall coordination, and medicines shortage management. Our goal is to optimise your quality and compliance operations so you can focus on delivering safe and effective products to market.
Partner with us to strengthen your quality framework, ensure ongoing compliance, and support efficient, compliant product supply across all stages of the product lifecycle.
We can help you
With a strong track record in quality and compliance, our team delivered measurable results in 2024 including the setup or maintenance of 5 Quality Management Systems, processing of 858 Product Quality Complaints, release of 80 batches, management of 720 purchase orders, and acquisition of 16 import permits. These figures reflect our deep industry knowledge and hands-on support across the full product lifecycle. We understand your unique challenges and are well positioned to optimise your quality operations and ensure compliance.
We build robust quality systems aligned with GMP and regulatory expectations to ensure consistent performance and compliance.
• Quality systems design and implementation
• Quality system audits
• Vendor assurance and management programs
• Preparation and review of Quality/Technical agreements
We support continuous quality oversight to maintain product integrity and meet regulatory requirements.
• Product quality complaint management
• Risk assessments and mitigation strategies
• Investigation and resolution of deviations/CAPAs
• Internal and external quality audits
• Product quality reviews
• Change control management
We help you navigate the complexities of product movement and supply logistics with a focus on regulatory compliance and operational efficiency.
• Licence and permit applications
• Release for Supply
• Release for Distribution
• Recall coordination and communication support
• Medicines shortage notifications and strategy
• Purchase order processing
Product quality complaints managed annually
Batches released in 2024
Purchase orders processed in 2024
Import permits obtained in 2024
Quality Management Systems set up or maintained in 2024
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Maria Dionyssopoulos
Head of Regulatory, Quality and Compliance
Maria has extensive experience in developing regulatory strategies and providing insightful regulatory advice to a variety of...
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