Biotechnology and therapeutic products

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:

Compliance

• Regulatory compliance, including under the current Medicines Act and regulations, Therapeutic Products Act (when it comes into force), 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.

Research

• 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.