About Us
Australian Regulation Pathways is a specialist consultancy supporting manufacturers of biologicals and medical devices as they navigate Australia’s regulatory landscape.
Our Mission
To provide independent regulatory representation that enables international manufacturers to enter, establish and maintain a compliant presence in the Australian market.
Through trusted guidance, evidence-based regulatory evaluation and ongoing sponsorship oversight, Australian Regulation Pathways provides clear and reliable pathways from initial market entry through to long-term regulatory compliance and continuity.
Who We Support
We support established global manufacturers, emerging companies and start-ups – whether you’re entering the Australian market for the first time or strengthening your existing regulatory foundations. Our role is to offer specialist, reliable regulatory expertise that helps teams progress with clarity and confidence.
We work with manufacturers requiring:
Regulatory Expertise Backed by Real-World Experience
The team is led by Magda Wojciechowski, a Regulatory Strategy and Clinical Evidence Specialist with experience across the full medical device and biological product lifecycle. Her background includes roles within universities, global medical device manufacturers, Contract Research Organisations (CROs), large corporate organisations and medical practices. This breadth gives the team a practical understanding of how regulatory, clinical and commercial functions connect.
Magda’s scientific background includes an undergraduate major in anatomy and histology and a PhD in lens cell signalling. With more than a decade of university teaching experience, she brings a strength in explaining complex scientific and regulatory concepts clearly and connecting information quickly a capability that underpins the team’s evidence‑led approach.
Our consultancy works as a collective of professionals with complementary regulatory, scientific and clinical experience. Team members bring backgrounds from universities, research groups, regulators, manufacturers and clinical environments, with expertise across a wide range of therapeutic areas. This diversity allows us to match the right capability to each project and support manufacturers through TGA submissions, sponsorship obligations, clinical evidence development and post‑market compliance.
We operate with an independent regulatory perspective, separate from study teams, CROs and distribution partners, ensuring advice is grounded in evidence, risk and regulatory requirements. By combining complementary expertise across scientific, regulatory and clinical domains, the team provides practical, structured support throughout the product lifecycle from early planning through to post‑market compliance.
Why Manufacturers Work With ARP
Manufacturers choose ARP when they require:
Planning Your Australian Market Access Strategy?
Whether you are evaluating Australian pathways, reviewing overseas approvals or considering Australian Sponsorship options, ARP can help determine the most appropriate regulatory approach.