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

    Resources and insights

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    Recent testimonials

    “A lawyer to discuss and debate approaches”

    Our startup needed advice on setting up the company, including shareholders’ agreements and all the other legal documents. Fiona had lots of excellent practical advice for startups to mitigate risk.

    With other firms, I haven’t always felt I got 100% attention. With Fiona, however big or small the client, everyone gets the same level of attention and focus.

    For us, getting something wrong could do more than cause the business to fail. We deal with registered medicines, so we could breach the regulations and not be able to sell our product.

    I wanted a lawyer to discuss or debate an approach’s pros and cons. Fiona has a very clear perspective, and she’ll share that view based on her experience. She’s fine if you go in another direction, but you’re never left wondering where you stand because her advice is opaque.

    A great thing about Argyll Law is that I know I’ll pick up the phone, and I won’t be passed to one of 15 different people. I’ll talk to Fiona. And I never get big bills based on all these people I never saw having reviewed my case.

    Read more

    James Jones
    Chief Commercial Officer,
    Anthia Life Sciences

    Everything about Australian law is completely different from US laws, so having Fiona as our resident director is fantastic.

    Fiona has a great international background, which is super helpful. She knows what we don’t know about Australia, and takes that into account to give us advice we understand.And I don’t have to go through 10 layers of secretaries and other lawyers to talk to Fiona. She goes out of her way to work with our time zones. It’s almost like having your own in-house counsel.

    Fiona’s like a part of the company. We trust her and I rely on her significantly for advice on many, many things.

    Read more

    July Bocabeille
    CFO,
    Performance Beauty Group

    “You don’t spend half the time explaining.”

    I was looking for a lawyer I could partner with because we don’t work in a cookie-cutter area. I need to have open-ended conversations, debating scenarios to find the right solution. Fiona’s a great sounding board.

    She’s also approachable and practical. And she’ll give very direct feedback if that’s what you want.

    Working with a lawyer with a strong knowledge of the healthcare sector means you don’t spend half the time explaining. You can get straight to the issue at hand. And even when Fiona doesn’t know an area specifically, she comes up to speed very quickly.

    Read more

    Martin Hayes
    Co-Founder,
    Mayes Healthcare

    Advice that makes me confident advising leaders

    We’re based in Texas with operations in four countries, so I value Fiona taking the time to help me truly understand Australian law and the information she’s giving me. She doesn’t send me high-level attorney language and leave me to figure it out.

    That matters a lot because Australian law is very different from US law. There are things in Australian law that I’ve never seen before.

    Fiona is communicative and fast to respond. She’s very sensitive to the fact that employee relations issues are sometimes really pressing.

    Because Fiona’s advice is detailed, I’m confident advising leaders about what’s happening in Australia. That means we’re managing our risk well.

    Read more

    Ryann Paschal
    Vice President Human Resources,
    Performance Beauty Group

    Keeps disputes from going to court

    Fiona’s experience in the international construction and dispute resolution area is the most critical thing for us because we have international and domestic supply contracts.

    Her experience means she can be proactive, helping us to make informed decisions and negotiate resolutions that benefit us and the customer. Fiona’s hit rate on keeping disputes from going too far is almost 100%, which protects our reputation and saves time, money and resources.She’s responsive, approachable and readily available. And her international experience means she frames her advice in ways that are useful to our head office overseas.

    Read more

    Virendra Ghodke
    Chief Executive Officer,
    Mageba (Australia) Pty Ltd.

    Saved us time and money

    I was referred to Fiona by a lawyer friend who assured me she’d take great care of us—and she did. Fiona provided professional, personalised attention without the big-firm red tape.

    Instead of dealing with multiple lawyers and confusing fees, Fiona handled everything directly and efficiently. She simplified our contracts, reducing two documents into one with an updateable schedule for each customer.Her expertise saved us time, money, and unnecessary stress. I highly recommend her for personalised and clear legal advice.

    Read more

    Lindy Milne
    Managing Director,
    PayOK

    “Honest, forthright and always there”

    Fiona started due diligence when we asked her to investigate our Australian operation because the director of our Australian company had gone rogue. She quickly found very big problems, including millions of dollars that were missing. She advised us to establish a new company and start proceedings to repossess a million dollars of inventory.

    Fiona worked with us step by step to set up a new company. She knew the ins and outs of what needed to be done, and gave us tons of good advice. She guided us on getting the employees and payroll set up, certifications with the government, opening the bank accounts, and making sure everything was done correctly.That included transferring the shares to me and setting me up as a foreign director. Fiona became our resident director.
    Everything was done in a couple of months.

    Along the way, Fiona was very kind and super professional. She was always polite to the person who had let us down while making sure he couldn’t cause us more damage. That person was close to us, and Fiona was very empathetic but practical.

    Fiona never tried to exploit a complicated, aggravating situation to charge us more. She was honest, forthright and always there. She cares.

    Read more

    Ian Clark
    Founder and CEO,
    Activation Products

    The difference between success and failure on a personal matter

    A partner in Fiona’s former firm recommended Fiona as the lawyer he would instruct himself even though Fiona was starting her own firm.

    My wife and I found Fiona to be a master communicator who quickly picks up things, understands the bigger picture, and bolts everything together very well. She’s so well organised with a very nice balance in her approach.

    Every response nailed it, just nailed it — well-weighted and precise.

    In court, we had the A-team. Fiona had two suitcases of documents and was passing the right papers to our barrister at the right time. The other side had two barristers, who were scrambling. It was like something from The Castle.

    We spent about $600,000 on this case, and if we’d lost, we would have paid similar costs again. Fiona gave us the confidence to proceed, and that confidence was justified.

    To get us there, Fiona went above and beyond. She made herself available outside normal business hours, worked on weekends, and handled time pressures like a pro. She was hugely invested in us winning.

    When my wife got to court to testify for the first time ever, she felt prepped and ready, thanks to Fiona.

    This was not just a legal case — it was personal, involving our home. Fiona was amazing at handling the emotional stress. She truly understood the personal impact on us and guided us through it with care.

    Without Fiona, we wouldn’t have won. It’s as simple as that. She was the difference between success and failure.

    Read more

    Tim Blumentals

    Far better prepared than the other side

    The way Fiona puts things together is exceptional; it’s diligent and thorough. In the cases that she’s handled for us, I’ve noticed we’ve been far better prepared than the other side. And, of course, that is the reason why we were successful!! It was only because of how diligent and how thorough Fiona is

    Some lawyers ruin a negotiation fighting over a point of law. Fiona gets the commercial element when she’s negotiating. She doesn’t push the legal points at the expense of reaching a good deal. That’s because she’s always listening to the client.

    Read more

    Sandro Ianni
    Head of HUB Region
    Oceania/South East Asia,
    LISEC Australia Pty Ltd

    Maintains the human touch for her clients

    Litigation can be a daunting maze, but Fiona was able to understand that it can be a rollercoaster, as well as break down what was happening so that we could work together effectively.

    Somehow, Fiona has maintained the human touch while being aggressive in pursuit of the right result for her client.

    Read more

    Ross Campbell
    Managing Director,
    HOMAG Australia Pty Ltd

    Probing questions to get results

    Fiona’s understanding of the business means she asks probing questions when we’re talking about a dispute or a claim we’re looking at pursuing.

    She gets her head around the issues quickly and cuts through to what matters, including the commercial reasons why we would pursue one case and not another. And then she keeps us focused on what’s important.

    She’s also able to use different strategies to get a positive result, not just litigation. If you can get the result you want without going to court, that’s excellent.

    Read more

    Malcolm Stewart
    Managing Director,
    Preformed Line Products (Australia) Pty Ltd

    Focused on the actual issues

    A common tactic in legal representation is for the other side to make claims and counterclaims to keep your lawyer distractedly spending your money chasing everything down. It’s a trap to wear you down and tie up your lawyer on things that aren’t the main point.

    Fiona doesn’t let that happen. She keeps the matter focused on the end goal and the actual issues.

    Also, with Fiona, you don’t get passed through the firm to people who might not understand your business. You’re dealing with Fiona, with her extensive network of colleagues and barristers.

    Read more

    Chad Brown
    CEO,
    James Glen Pty Ltd

    Rapid grasp of key concepts in complicated matters

    Even though our matter was involved, and I had to send through a lot of documentation, Fiona grasped the whole overview and concept of everything really, really quickly.

    I was surprised how little we had to explain. Instead, she quickly gave us a detached, professional opinion about whether our case was worth pursuing.

    With Fiona, it’s not like sitting with lawyers in boardrooms, getting bombarded or feeling like you’re a nuisance. It was actually pleasant.

    Read more

    Michel Scheuble
    Managing Director,
    Fracht Australia Pty Ltd

    Excellent cross-cultural communicator

    Fiona immediately understood the size of our business and the scale of our problem — being treated dismissively by a larger company. She knew exactly how to defend us. Now, they know her by name in the home office and often ask for her opinion.

    Fiona is a great lawyer and an adept cross-cultural communicator. She’s insightful, listens well and provides seasoned advice with great customer service.

    We appreciate that our work isn’t handed down to a junior associate; it’s handled by Fiona herself with all her skill. And with her experience, she quickly understands our context and the situation, and gives it due consideration and comes back with options that I would not have come up with myself.

    Read more

    Dan Credazzi
    Country Manager,
    Australia & New Zealand, DNV Imatis AS

    Achieved all our goals

    We found a competitor had substantially copied part of our software so asked Fiona to provide advice regarding our legal options and also how to manage aspects of the media communications.

    The outcome was better than we expected, and we achieved all our goals. Fiona’s advice was invaluable.

    Read more

    Hans Egger
    The Modern Adviser
    Co-Founder Astute Wheel

    Very capable in complex matters

    Fiona works hard, is extremely motivated and positive, very capable in complex legal matters, realistic and very successful. At the same time she is a nice person too.

    Wolfgang Bennedik
    Former Managing Director,
    Connect Hearing Australia Pty Ltd

    Strong team member

    Fiona has provided the NACC and its members with valuable advice, and been instrumental in the chamber’s growth. Fiona is a strong team member and I highly recommend her and her work.

    Sophia Demetriades Toftdahl
    President,
    Norwegian Australian Chamber of Commerce

    Using the law to get the right outcomes

    Fiona is an exceptional lawyer who blends her ethics and morality into the way she practices law. Rather than using the law as a weapon, she leverages it as a guide to get the right outcomes.

    All of the business and personal matters Fiona has handled for us have been dealt with professionally and successfully.

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    Phillip Evans
    Founder, Managing Director
    eeStrategy

    Culturally sensitive and tactful — but frank

    Fiona’s assistance has been invaluable in negotiating the terms of several joint venture agreements and in resolving a few potentially expensive disputes, avoiding the need to commence court proceedings.

    Fiona’s legal advice is always honest, practical and commercial. She has the ability to analyse a problem and master the detail whilst not losing sight of the big picture and commerciality of the situation. She explains complex legal concepts clearly and at a level that can be easily understood and applied in a commercial context.

    At times her advice has needed to be frank and not necessarily what I wanted to hear. In those circumstances, she has always managed to communicate that advice with tact and understanding.

    In addition to being an excellent lawyer, I have really appreciated the respect and sensitivity which she has shown towards my indigenous cultural heritage.

    Read more

    Scott Franks
    CEO,
    Tocomwall Pty Ltd

    Negotiating excellent results

    Fiona has saved us a lot of money negotiating complex contracts with large corporate venues. Her skills negotiating with difficult individuals and keeping track of the details while not losing sight of our broader goals are fantastic.

    She achieved a great outcome for us every time.

    She’s also helped me to be across the myriad legal issues and requirements that are often overwhelming when you don’t have in-house lawyers.

    I am so grateful for her expertise, friendly manner and integrity.

    Read more

    Ainsley Poulos
    Director,
    Eastside Speech Solutions

    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
    Book a consultation