Expert Life Sciences & Healthcare Lawyers
Life Sciences law covers a broad range of matters related to the development, production and distribution of medical devices, pharmaceuticals, and biotechnological products. It helps ensure the safety and efficacy of medical technology. Healthcare lawyers require extensive knowledge of the regulatory entities and relevant laws.
If you are looking for a Healthcare & Life Sciences law firm in Sydney, or for further information in relation to Life Sciences & Health Care, contact any member of our Commercial Law Team.
What To Expect From A Life Science Lawyer
The pharmaceutical, biotech and medical devices sectors have been impacted by a changing global landscape. Increased governmental regulations, new medical technologies, a shift in age demographics and the steady inflation of healthcare have all proved powerful market forces.
To meet these challenges, Atkinson Vinden helps our clients integrate their practices with the health industry’s regulatory and legal frameworks. Our health lawyers have vast experience with navigating the complex legal environment that accompanies all stages of the company’s life cycle.
The life cycle of life sciences companies is not typical to that of other industries, and requires expert handling. A major prerequisite for the life cycle of life sciences is the need to formally apply to national regulatory organisations to secure market approval. Market approval requires comprehensive research data that demonstrates product safety, quality and efficacy. Human clinical trials are mandated under the Good Clinical Practice (GCP) standards, as referenced by the International Conference on Harmonisation (ICH). If a trial is not compliant with GCP standards, it is automatically invalid in Australia according to the Therapeutic Goods Regulations 1990.
Regulatory approval is a key milestone in the product’s life cycle, and marks the beginning of revenues. This period is often accompanied by the need to secure reimbursement through either the Pharmaceutical Benefits Scheme (PBS) or the Medical Benefits Scheme (MBS).
Ultimately, the process from product conception to commercialisation can take years due to the overwhelming intricacies and legal criteria that need to be fulfilled. As a result, companies often seek an independent life sciences law firm to help simplify this process.
A healthcare lawyer can provide assistance in areas such as regulatory consulting, compliance review, intellectual property and more.
Learn about the services our life science lawyers provide below.