Ensuring compliance with Therapeutic Goods Administration (TGA) standards is crucial for businesses and professionals operating in the therapeutic goods space. Rapidly changing regulations, often in response to evolving social attitudes, add an extra layer of complexity. Featherstone & Associates acknowledges the dynamic nature of the health, sciences and medical sectors and provides specialised guidance and support to navigate the intricacies of TGA compliance.
Navigating TGA Regulatory Framework
The TGA plays a pivotal role in safeguarding public health by regulating the supply, import, export, and manufacturing of therapeutic goods in Australia. Featherstone & Associates possesses a deep understanding of the TGA regulatory framework, providing clients with tailored legal solutions to ensure compliance with applicable laws and standards.
Greenwashing and TGA Compliance in the Beauty and Health Sectors
As consumer awareness grows, issues such as greenwashing have become a major focus, particularly in the beauty sector. Greenwashing involves misleading marketing claims related to environmental and health benefits.
Featherstone & Associates recognises the significance of addressing this concern and offers specialised services to beauty sector brands, medical professionals, and health-related businesses to ensure their marketing claims align with TGA regulations and are not misleading to consumers.
Key Areas of TGA Compliance Services
- Product Registration: We assist businesses in navigating the TGA product registration process, ensuring that therapeutic goods meet safety, efficacy, and quality standards.
- Labelling and Advertising Compliance: We guide clients in developing accurate and compliant labelling and advertising materials, ensuring transparency and preventing potential issues related to greenwashing.
- Clinical Evidence and Substantiation: For health and medical professionals, we provide support in gathering and presenting the necessary clinical evidence to substantiate therapeutic claims, meeting TGA requirements.
- Navigating Post-Market Obligations: TGA compliance doesn't end once a product is in the market. We guide businesses through post-market monitoring, adverse event reporting, and other obligations, ensuring they remain compliant throughout the product's lifecycle.
- Response to TGA Enquiries & Inquiries: Should the TGA have concerns or inquiries, a swift and accurate response is crucial. We stand by our clients, offering timely advice and representation in any interactions with the TGA.
- Risk Assessment and Management: We conduct comprehensive risk assessments to identify potential compliance risks and implements risk management strategies to mitigate these risks effectively.
- Educational Support: Education is a cornerstone of our service. We provide clients with the knowledge and resources needed to stay informed about evolving TGA regulations, fostering a culture of continuous compliance within their organisations.
Why Choose Featherstone & Associates for Health, Science & Medical Legal Support?
- Holistic Expertise: Featherstone & Associates stands at the intersection of law, health sciences, and business management. Our multidisciplinary team, led by Roisin Featherstone, uniquely combines legal proficiency with scientific insight, offering comprehensive support tailored to the health, science, and medical sectors.
- Proven Track Record: With a background in commercial litigation, regulatory compliance, and risk management, our team has successfully assisted clients across diverse industries. From navigating regulatory investigations to providing strategic legal advice, we aim to consistently achieve favourable outcomes for our clients.
- Client-Centric Approach: Understanding the unique challenges faced by businesses in health, science, and medical domains, we adopt a client-centric approach. We prioritise your needs, offering personalised solutions that align with your industry's specific legal and regulatory landscape.
- Scientific Insight: Roisin Featherstone's qualifications in biomedical science and medical laboratory science bring a valuable dimension to our legal services. This scientific expertise enables us to interpret complex medical and scientific data, contributing to a more thorough and effective legal representation.
- Strategic Advisory: Beyond legal counsel, we offer strategic advisory services aimed at empowering businesses in the health sector. Whether it's regulatory compliance, contractual agreements, or risk management, our team provides proactive guidance to help you navigate challenges and seize opportunities.
- Commitment to Education: Featherstone & Associates is not just a legal service provider; we are advocates for knowledge sharing. Our commitment to education is reflected in our efforts to empower clients with a deeper understanding of legal complexities, fostering a collaborative and informed approach to decision-making.
A Partner for the Journey
Our relationship with you isn't transactional; it's a long-term partnership. We are here to be your trusted advisor. In the health, science and medical sectors, where innovation and compliance intertwine, we extend the same commitment.
Our relationship with your practice or startup is more than just legal counsel – it's a collaborative journey. As your business or practice evolves and faces new challenges, particularly with increasing regulatory demands, we stand ready to adapt our legal experience to ensure your ongoing success.
Complete our Enquiry Form or email us at contact@featherstone.law today to arrange a free, no obligation discussion about your matter.