COMPLIANCE REGULATORY

Support you navigating the complex Australian TGA compliance regulatory compliance landscape.

The Australian regulatory body, TGA (Therapeutic Goods Administration) is part of the Australian Government Department of Health and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Our team has the expertise to guide you through the complexities of manufacturing processes and legal procedures for acquiring cGMP status. Our experts have been working closely with TGA and other regulatory bodies such as FDA and EMA in the past and have built close relationships with them. In addition, we have an international network of experts within Australia and overseas.

The ADDTEC compliance-regulatory team can support you to ensure:

• Regulatory compliance fit with the GMP status and the requirements
• SOP-related violations are effectively managed
• Strong corporate governance
• Compliance that’s consistent with the entity’s commercial objectives.

Our people take part in regular training and are active in professional and technical committees. We express our views and perspectives through these committees and direct engagement with the regulators. It’s this approach that enables us to proactively help you stay on top of today’s ever-evolving international regulatory compliance landscape.