Gateway to Australia's Healthcare Market
Regulatory Affairs • Drug Safety • Medical Affairs Services
Unlock new opportunities for your medicines & medical devices while we handle regulatory affairs & drug safety compliance
Regulatory Compliance and Pharmacovigilance Services
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 medicine or treatment, 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.
We are a dedicated team with extensive expertise in regulatory affairs, drug safety (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)
- regulatory affairs strategy
- 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 and encompass Prescription Medicines such as small molecules, biotechnology products and biologicals (e.g. faecal microbiota transplant, tissue-based and cell-based products), 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:
- create distinctive products in a crowded marketplace
- achieve the best outcomes for new products while maintaining regulatory compliance
- achieve growth in Australian marketplace
- optimise operational effectiveness including those for regulatory affairs and drug safety
- navigate healthcare and regulatory reforms
- establish Australian affiliate / subsidiary
- build company infrastructure that meets requirements of Australian regulators and supports product distribution