Providing services for Australian companies and for companies looking to enter the Australian market.

Australia

Consulting Services

Whether you are an Australian company seeking to establish yourself in your Australian home market, or an overseas company looking to enter the Australian market, we can assist you with negotiating your way through TGA, NATA or other regulations to get your product onto the Australian market.

Services Offered

The services we can offer you in Australia include:

• Quality Assurance – writing and establishing quality and other management systems.
• Regulatory Affairs – assistance with obtaining marketing clearance or approval for your product.
• Clinical Trials – assistance in writing all the relevant documentation to conduct an Australia-based clinical trial, as well as clinical trial monitoring services.
• Reimbursement – listing on the Prosthesis List, or MSAC/PBS listing.
• Business Writing – need a business plan or information memorandum written? We can help with that too!
• Medical and Scientific Writing – don’t have time to write up your results into a paper or abstract, we can do that for you!
• Grant Writing – many grants are available for companies and each requires a considered approach, with clear and concise writing.
• Sponsorship – a local presence for companies not based in Australia./li

Our Australian Consultants

Our Australian-based consultants have a breadth of experience, including with quality assurance (and other documented management systems), regulatory affairs, clinical trials and reimbursement for a variety of products, including medical devices, in vitro diagnostics, pharmaceuticals, OTCs, complementary medicines, biologics, etc.

Don’t hesitate to contact us for a confidential discussion on how we can help you.