New service!: Australian Sponsor
Navigating the regulatory landscape for medical devices, cosmetics, and therapeutic goods in Australia can be challenging, especially for international manufacturers. To access the Australian market, non-Australian manufacturers must appoint an Australian Sponsor—a vital role in ensuring regulatory compliance. AF Pharma is proud to announce that we now act as an Australian Sponsor, providing end-to-end support for your regulatory needs.
What is an Australian Sponsor?
An Australian Sponsor is a legal entity based in Australia responsible for ensuring that products meet the requirements set by the Therapeutic Goods Administration (TGA). This role is crucial for registering, importing, and distributing products within Australia.
Key Responsibilities of an Australian Sponsor (AU Sponsor)
1. TGA Product Registration
The sponsor handles the submission of applications for inclusion of products on the Australian Register of Therapeutic Goods (ARTG).
2. Regulatory Compliance
Sponsors ensure that products meet TGA standards for safety, quality, and performance, including adherence to the Therapeutic Goods Act 1989 and associated regulations.
3. Post-Market Surveillance
The sponsor monitors product performance in the Australian market, manages adverse event reporting, and ensures corrective actions are taken when necessary.
4. Communication with the TGA
As the local point of contact, the sponsor liaises with the TGA on behalf of the manufacturer for audits, inspections, and other regulatory matters.
5. Importation and Labeling
Sponsors ensure that products comply with importation requirements and that labeling meets Australian standards.
Why Appoint AF Pharma as Your AU Sponsor?
AF Pharma brings expertise, reliability, and a deep understanding of Australia’s regulatory framework. Our services include:
ARTG Registration Support: Ensuring smooth product registration and market access.
Regulatory Guidance: Assisting with compliance for medical devices, cosmetics, and supplements.
Post-Market Vigilance: Managing incident reporting and monitoring product performance.
Local Representation: Acting as your direct link to the TGA for timely responses and efficient communication.
Benefits of Working with AF Pharma
Experience Across Multiple Markets
With a strong foundation in EU, UK, and US regulations, AF Pharma offers unparalleled insights into aligning global strategies with Australian requirements.
Seamless Market Access
We ensure that your products meet TGA requirements, minimizing delays and streamlining your entry into the Australian market.
Proactive Compliance Management
Stay ahead of regulatory updates with our dedicated team of specialists, ensuring your products remain compliant throughout their lifecycle.
Ready to Enter the Australian Market? With AF Pharma as your Australian Sponsor (AU Sponsor), you can focus on innovation and growth while we handle the complexities of regulatory compliance.
Contact us today to learn how our expertise can help you succeed in Australia.
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