Gateway to Australia's Healthcare Market
Regulatory Affairs • Drug Safety •Medical Affairs Services
Unlock new opportunities for your medicines and medical devices in Australia while we handle regulatory affairs and drug safety compliance
Expert Pharmaceutical Consultants
Regulatory Affairs, Pharmacovigilance, Medical Affairs and New Business Development | Experts in • Small Molecule Medicines • Biotech Products • Biologicals • Medical Devices • Cosmetics
At Hilaxon, we are driven by a mission: to ensure that every Australian has access to the most appropriate medicines an treatments, including specialised medicines such as biotech products and biologicals as well as medical devices, to live their life to the fullest regardless of who they are, where they live, or what their medical condition is.
Our dedicated team possesses extensive expertise in regulatory affairs, drug safety (aka pharmacovigilance), medical affairs and business development. We understand the distinct challenges of entering the Australian healthcare market and partner closely with clients to deliver strategic, seamless support. Our services enable organisations to navigate regulatory compliance and competitive landscapes with confidence, achieve efficient and successful product launches, and realise sustainable commercial growth.
Specialised Services
Some of the specialised projects we are currently assisting our clients with are:
- new product development and commercialisation (R&D) of biologicals and medical devices
- regulatory affairs strategy for medicines
- regulatory gap analysis and dossier bridging
- new product registrations in Australia
- literature based submissions
- product life-cycle management
- pharmacovigilance
- process design and implementation
- Clinical Study Reports, Summaries and Overviews
- Toxicology Study Reports, Summaries and Overviews
Broad Expertise
Our expertise extend beyond pharmaceuticals to include wide range of medicines, such as Prescription Medicines including small molecules, biotechnology products and biologicals (e.g. faecal microbiota transplant, tissue-based and cell-based products). We also cover OTC - Over the Counter Medicines, Medical Devices and Cosmetics. We work across strategy, R&D, operations, and commercial fields to assist our clients with challenges in areas such as:
- creating distinctive products in a crowded marketplace
- achieving the best outcomes for new products while maintaining regulatory compliance
- driving growth in the Australian marketplace
- optimising operational effectiveness including those for regulatory affairs and pharmacovigilance
- navigating healthcare and regulatory reforms
- establishing Australian affiliate / subsidiary
- building company infrastructure that meets requirements of Australian regulators and supports distribution of medicines and medical devices