Our lawyers have significant experience in advising on the regulatory issues involved in the following highly regulated industries in Australia: pharmaceutical, agricultural chemical, medical devices and biotechnology. Our team provides regulatory advice across the following:
|
- The operation and effect of the Australian Therapeutic Goods Act (1989) and associated regulations.
- The role of, operations and decisions of the Therapeutic Goods Administration (Australia's equivalent body to the US FDA).
- The registration and approval processes for therapeutic goods and medical devices in Australia.
- The regulatory approval process for agricultural chemicals.
- Clinical trial regulation in Australia, including clinical trial agreements and GCP compliance.
- The Commonwealth pharmaceutical reimbursement program, the PBS.
- Genetically modified organism (GMO) regulation.
- Biodiversity legislation.
- Functional foods and nutraceuticals.
- Food standards and GM food labelling issues.
|
|
Please contact one of our lawyers listed on the right for further advice.
|
Click here for our Regulatory Brochure
|
