Coreline Consulting - Biomedical Consultancy Experts

About US

At Coreline Consulting, we support pharmaceutical, medical device, and biologics companies in navigating the complexities of regulatory compliance. Our expertise covers prescription medicines, listed and OTC medicines, medical devices (including custom-made devices), blood and tissue banks, and export-only products. We deliver clear and practical solutions to meet the requirements of the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand, while also aligning with international regulatory standards.

Our Director, a Chartered Biomedical Engineer (CPEng), RPEQ, MIEAust, and NER-registered professional, brings together engineering precision and regulatory insight. With extensive experience in the biomedical and healthcare sectors, he understands the technical and compliance challenges organisations face. This unique perspective allows us to design tailored, end-to-end strategies that ensure compliance, minimise risk, and support faster market access.

We see ourselves not just as consultants, but as long-term partners in your compliance journey. Through technical excellence and a client-focused approach, we help organisations of all sizes meet their regulatory obligations with confidence. Guided by our values of integrity, efficiency, and precision, we provide peace of mind that your compliance needs are managed by experts committed to quality and results.

Our Mission

Our mission is to simplify regulatory compliance for pharmaceutical, medical device, and biologics companies by providing clear, practical, and reliable guidance. We are dedicated to helping our clients meet the standards of the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand, while also aligning with international best practices such as ISO 13485. By bridging the gap between technical expertise and regulatory requirements, we enable companies to bring safe, effective, and compliant products to market with confidence.

We are committed to being more than just advisors — we aim to be trusted partners in every stage of our clients’ compliance journey. Guided by our values of integrity, efficiency, and precision, we focus on delivering tailored solutions that reduce risk, streamline processes, and support innovation in healthcare. Our purpose is to make regulatory compliance straightforward and achievable, empowering our clients to focus on what they do best: improving patient outcomes

Coreline Consulting transformed our medtech idea into reality with their expert guidance and support. Their holistic approach made all the difference!

John D.

★★★★★

Working with Coreline Consulting gave us complete confidence in meeting TGA and Medsafe requirements. Their expertise simplified the entire process and saved us valuable time!

Peter H.

★★★★★

Thanks to Coreline Consulting, we achieved market approval faster than expected. Their attention to detail and commitment to quality were outstanding!