Health, life sciences and biotech

Expand your market presence, develop new technologies and enhance operational efficiencies

Cosmetics, cleaning products and industrial chemicals
Health, life sciences and biotech
Manufacturing Equipment
Mining equipment, technology and services

Abundant opportunities in Australia’s health, life sciences and biotech industry

Navigating legal pathways for global innovators to thrive in Australia

The Australian life sciences and biotech market is worth more than $250 billion and is growing rapidly. Hungry for the benefits of imported products, from biotechnology and pharmaceuticals to cosmeceuticals, medical devices and clinical trials, opportunities are abundant.

We provide dedicated support for our international clients in life sciences, health and biotech. We handle the complexities of the law, so you can concentrate on achieving commercial success.

Entering the Australian market confidently

Australia has a mature market and an established transparent legal framework. However, obtaining TGA approval, and setting up or finding an Australian sponsor requires compliance with multiple regulations administered by different Australian regulators and government departments.

The key to effectively establishing your Australian operation and achieving your commercial goals is legal advice tailored to the intended scale and style of your business in Australia.

We navigate the regulatory complexity for our clients to ensure they have the right structures to successfully import and supply health products into Australia.

We partner with you to:

Health

including understanding:

  • which products ‘make health claims’
  • getting the right sponsor:
    • available options for a sponsor: your distributor, establish an Australian subsidiary, or engage a registration-holding company
    • the duties and responsibilities your sponsor must fulfil during the TGA approval process and to support your business after registration
    • setting clear expectations for your sponsor through a well-drafted agreement.
  • providing sponsorship services
  • providing an address for product labels
  • helping you to set up a clinical trial and take advantage of Australia’s lucrative research & development tax incentive.
  • design and establish the best business structure to meet your Australian and overseas commercial objectives
  • ensure your parent entity is protected as far as legally permissible from Australian damages claims
  • manage all your corporate and registration requirements for a branch office or foreign-owned subsidiary business structure
  • ensure your distribution agreements are appropriate for the Australian market
  • prepare your contractual documents
  • advise on your employment contracts for any Australian employees and ensure your compliance with Australian statutory obligations to employees
  • review your standard contract clauses to ensure they can be defended in Australia
  • ensure your Australian operations comply with tax, consumer protection and environmental requirements
  • ensure your work health and safety duties are understood and implemented
  • advise on your intellectual property protection.
including:

  • cross-border disputes
  • contractual disputes
  • intellectual property protection
  • consumer protection disputes
  • enforcement of distribution agreements, including compelling sponsorship transfers
  • urgent injunctive relief to protect your interests.
We ensure your assets and operations are safeguarded.
With your legal affairs safely in our hands, you can concentrate on your business goals. Whether it’s expanding your market presence, developing new technologies, or enhancing operational efficiencies, we are your trusted partner to ensure the legal side is covered.
We understand that each business has unique needs. Our approach is tailored to match your specific requirements, ensuring you receive relevant and effective legal guidance.
The health, life sciences and biotech sector is dynamic and requires a deep understanding of both legal and industry trends. Our expertise means you’re always ahead of the curve, legally and commercially.
Our decades of experience working with businesses from Europe, the UK, the US and specifically those from German-speaking countries and Norway, ensures seamless entry and operation in the Australian market.

Important: What if your product needs TGA approval?

If your product makes a health claim, it must be approved by Australia’s Therapeutic Goods Administration (TGA). Crucially, Australia makes a broad view of what is a “health claim”.

Find out what this means for you legally in our guide to entering the Australian market confidently when you need TGA approval. Enter your details below and we’ll email you a copy of the guide.

    Key Contact

    Fiona Henderson

    Director
    Read profile

    International
    client base

    Our clients are overseas companies ranging from niche operations to multinationals with thousands of employees and billions in turnover. Every client receives the same detailed attention and dedication to their commercial goals.

    Australian lawyer representing Germany clients
    Australian lawyer representing Austria clients
    Australian lawyer representing Switzerland clients
    Australian lawyer representing Norway clients
    Australian lawyer representing Italy clients
    Australian lawyer representing USA clients

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    Looking for an Australian lawyer
    experienced in litigation and cross-border matters?

    If you’re looking for experienced Australian lawyers to represent and protect your interests in Australia,
    please let us know how we can help.

    +61 2 9173 9894
    Free consultation