Navigate Up
Online services


Life sciences

Biotechnology, pharmaceutical and medical device companies put innovation at the centre of their business life, yet they operate within a strict legal and regulatory framework.  The inherent risks surrounding product development and usage and business strategy, call for legal advice that is more than technically excellent.
Lawyers who are more than legally qualified
Members of Gadens’ life sciences team are tertiary qualified health and science professionals, giving us exceptional understanding of the unique legal challenges facing this sector. 
True industry understanding
Our responsive advice helps to safeguard our clients’ businesses, innovations and strategies, and to promote and foster efficiency and effectiveness in their organisations.  We partner with them to assess, monitor and manage legal risk, and advise on a significant variety of commercial issues.
These range from the importation of medical devices and human tissue to mergers, acquisitions, IPOs, product matters, regulatory regimes, compliance and statutory breaches, intellectual property and product recall.
Our clients include medical device, pharmaceutical and complementary medicine organisations, health and allied health providers (including pathology and radiology practices, hospitals and nursing homes) and health care insurers.
Experience
  • Advising on the Therapeutic Goods Act 1989 (Cth), including listing of goods on the Australian Register of Therapeutic Goods and  the requirements for and steps involved in obtaining a conformity assessment certificate
  • Advising on labelling and presentation of therapeutic goods under to the requirements of the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Regulation 1990 (Cth), the Therapeutic Goods Advertising Code, the Standard for the Uniform Scheduling of Medicines and Poisons, Therapeutic Goods order No. 69 and the Required Advisory the regulatory requirements and advertising, labelling and packaging of therapeutic goods and alleged breaches of the Therapeutic Goods Act 1989 (Cth)   
  • Advising on the validity of complying with various notices issued to the Therapeutic Goods Act 1989 (Cth), including section 41JA notice and acting in applications for review of administrative decisions before the Commonwealth Administration Appeals Tribunal
  • Advising on the importation of therapeutic products and human tissue
  • Advising on applications before human research and animal ethics committees when seeking approval for clinical trials and drafting clinical trial agreements  
  • Advising on scheduling of drugs under the Poisons and Therapeutic Goods Act 1966 (NSW) and 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 on consent issues concerning medical treatment, human research and end of life
  • Advising on preparing clinical evidence that complies with the requirements of Part 8 in Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (NSW)
  • Advising on 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 IPOs in health care and life sciences and regularly advising on directors' duties, due diligence investigations, pre IPO structuring, employee share schemes, corporate governance and related matters and drafting a company indemnity program for all subsidiaries of a multi national company operating in the Asia-Pacific region.

Subscription information for legal updates

Request the latest legal news delivered direct to your inbox! Our experienced lawyers regularly prepare legal updates on a wide range of topics. Please fill in this form and hit 'subscribe' to receive publications in the areas you're interested in.

Fields marked with * are compulsory

                   
 
 
 

If you have a contact at Gadens, please enter their name here.

Choose your areas of interest













Gadens Lawyers respects the privacy of your personal information as outlined in our privacy policy. At any time, if you wish to unsubscribe from this service or to view or modify your personal details, email publications@nsw.gadens.com.au or follow the instructions in the publications delivered to your inbox. At our discretion, Gadens Lawyers may decide whether to approve your subscription request and may suspend or cease your subscription at any time.
.