- Biotechnology
- Pharmaceuticals
- Medical Devices
- Regulation and Compliance
- Financing
- Mergers and Acquisitions
gadens lawyers' dedicated life sciences team offers more than technical excellence. In addition to holding legal qualifications, our life sciences team has health professional and science qualifications, providing us with an exceptional understanding of the issues facing the life science industry and the ability to offer a highly commercial service.
Our lawyers are members of relevant industry organisations. Wendy Blacker is an Associate Member of ARCS (formerly the Association of Regulatory and Clinical Scientists), the Medico-Legal Society, the Australian Forensic Science Academy and the Defence Research Institute. Wendy is also a member of the Human Research and Ethics Committee, University of Sydney and is an honorary member of the academic staff in law and ethics in Postgraduate Studies in Pharmaceutical Medicine & Drug Development at the University of New South Wales.
The pharmaceutical and medical device industries have, at their core, a statutory obligation to ensure that their products are of quality and are safe and effective. This provides an ongoing challenge for an industry that is highly innovative and must rapidly adapt to change.
experience you can rely on
- advising in relation to the Therapeutic Goods Act 1989 (Cth), including the listing of goods on the Australian Register of Therapeutic Goods, advertising, labelling and packaging of therapeutic goods and alleged breaches of the Therapeutic Goods Act 1989 (Cth), including acting on behalf of defendants in proceedings where breaches of the Therapeutic Goods Act 1989 (Cth) have been prosecuted
- advising and acting for pharmaceutical corporations and complementary medicine organisations in applications for review of administrative decisions before the Commonwealth Administration Appeals Tribunal
- advising in relation to the importation of medical devices, therapeutic products and human tissue
- advising in relation to applications before human research and animal ethics committees when seeking approval for clinical trials and drafting clinical trial agreements
- advising in relation to scheduling of drugs under the Poisons and Therapeutic Goods Act 1966 (NSW) and advising in relation to the Standard for the Uniform Scheduling of Drugs
- drafting product recall procedures and acting in product recall matters, including the recall of therapeutic goods, food, manufacturing components and consumer products
- advising in relation to consent issues concerning medical treatment, human research and end of life
- advising in relation to Part IV and Part VA of the Trade Practices Act 1974 (Cth)
- advising in relation to cross border litigation involving medical devices and conflict of laws
- acting in the defence of product liability claims involving medical devices
- acting for issuing corporations and underwriters on initial public offerings in diverse industry sectors including health care and life sciences and regularly advising in relation to directors' duties, due diligence investigations, pre IPO structuring, employee share schemes, corporate governance and related matters
- acting on acquisitions and divestments, by way of takeover, IPOs, trade sale, scheme of arrangement of businesses and corporations across a wide range of industries including health care
- acting on the buy and sell sides of private equity transactions and for private equity investors and investee companies on fund raising and investment activities
contacts
Sydney: Wendy Blacker E wblacker@nsw.gadens.com.au
Charles Cowper E ccowper@nsw.gadens.com.au
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