Regulatory Strategy CROs in Australia

Melbourne-founded CRO supporting small and mid-sized biotech companies across all clinical development stages including regulatory affairs, biometrics, and manufacturing scale-up.

Australian full-service CRO providing Phase 1–3 clinical trial management with expertise in biotech-focused programs. Known for the Australian Clinical Trial Notification (CTN) regulatory pathway advantage.

ISO 9001-certified full-service CRO with offices in Australia, Singapore, and India providing Phase I-IV trial management across the Asia-Pacific region.

Australian full-service CRO focused on early-phase clinical trials in oncology, rare disease, and dermatology, leveraging Australia's Clinical Trial Notification scheme for faster trial start-up.

Melbourne-based CRO specializing in Phase I-IIa first-in-human studies, offering rapid trial startup under Australia's CTN scheme with access to leading Australian clinical pharmacology units.

Asia-Pacific focused full-service CRO providing clinical trial management, data management, and biostatistics services with particular expertise in cardiovascular, renal, and diabetes trials.

ICON's Australian operations leveraging Australia's CTN scheme for rapid Phase I trial initiation, supporting multinational sponsors with early-phase development in the APAC region.

Australian not-for-profit pharmaceutical company developing and registering medicines for neglected tropical diseases, providing regulatory and clinical development services for global health products.

Australian boutique CRO specialising in early-phase and first-in-human MedTech clinical trials across Australia, New Zealand, and the USA.

Asia-Pacific specialist CRO providing full-service clinical development capabilities with deep expertise in the Asia-Pacific regulatory landscape.

Australian pharmaceutical research company providing preclinical and clinical development services with expertise in inflammatory bowel disease and gastrointestinal therapeutic areas.

Australian CRO helping global pharma and biotech leverage the regulatory and cost advantages of clinical trials in Australia and New Zealand.

Independent Australian full-service CRO specializing in pharmaceutical, medical device and biotechnology clinical trials, award-winning APAC CRO of the Year.

Physician-led Australian CRO offering full-spectrum clinical and non-clinical services with AI-driven operating model across Phase I-III for innovative biotechs.