We help clients achieve seamless regulatory approvals with a strategy tailored to Australia’s TGA framework and compliance. Some of our popular services include:
Our senior consultants bring decades of hands-on experience across small molecules, biotech products, biologicals, medical devices and cosmetic. Our clients trust us with high-stakes filings and complex product types. They rely on us for strategic input and to ease the pressure on lean in-house teams.
For a US-based biologicals company, we authored over 1,500 pages of a hybrid submission supported by over 80 medical literature publications to secure TGA approval for desired gastroenterology indication.
We supported a European pharmaceutical client in resolving a decade long manufacturing oversight related to their recombinant DNA medicine. By guiding root cause analysis and corrective actions, we helped avoid recall and regulatory penalties, preserving the product’s market access in Australia.
A global pharma client relied on us during an urgent out of compliance event involving a critical Rx product, which is a specialised medicine with no therapeutic equivalent. We coordinated all TGA and regulatory affairs communications to ensure market continuity and avoid disruption to patient care, including the management of medical devices where necessary.
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