We help a wide range of clients who research, develop, manufacture, import, export, and distribute biotech and therapeutic products. We also advise policy makers in relation to therapeutic products.
Our clients include:
- Biotech, pharmaceutical and medical device companies
- Industry bodies
- Crown entities
- Health care providers
- Animal health companies
- Venture backed start-ups
- Research institutions.
As a full service firm with dedicated health sector specialists, we understand the context in which biotech and therapeutic products are used; the organisations, health professionals and customers who use them; and the regulatory environment.
We can support you with the following aspects of your business:
- Regulatory compliance, including under the current Medicines Act and regulations, proposed Therapeutic Products Bill, the Human Tissue Act, Human Assisted Reproduction Technologies Act, and Hazardous Substances and New Organisms Act
- Marketing, advertising, and promotional activities, including to healthcare professionals and end consumers
- Therapeutic product recalls
- Competition issues.
- Clinical research and trials, including regulatory requirements and ethics committee processes, negotiating and advising on clinical trial agreements, resolving participant claims, managing health information, and advising on research policies
- Tax advice, including about R&D (research and development) tax incentives
- R&D agreements, and Government funding agreements.
Commercial and intellectual property
- Commercial contracting, such as IP and technology licences, confidentiality agreements, distribution agreements, manufacture and supply agreements (including significant medical equipment subject to the Radiation Safety Act) and OEM agreements
- Applying for, or protecting, patent, copyright and trademark rights.
Corporate and structuring
- Due diligence, including analysis of all issues specific to the industry, and sale and purchase agreements
- Business formation processes and start-up financing, including venture capital finance
- Structuring investment in the bio-sciences industry, including any relevant tax structuring
- Pharmacy licensing, ownership, and corporate structuring.
Therapeutic Products Bill
We have supported a range of private and public sector clients and industry associations to understand the implications of the Therapeutic Products Bill, and advocate for changes to the bill.
Supply of COVID medication
We advised AstraZeneca on the supply of COVID-19 related pharmaceuticals, and assisting with contractual arrangements with the Crown.
Distribution and supply arrangements
We advised a US based medical device supplier on New Zealand distribution and supply arrangements, and advertising to the public and healthcare professionals.
Application of the Medicines Act
We advised on the potential application of the Medicines Act 1981 to a range of common consumer products.
DNA testing regulation
We advised on the regulation of direct to consumer DNA testing.
Toll manufacturing contract
We advised a Crown Entity on negotiating a toll manufacturing contract.