We help clients achieve seamless regulatory approvals with a strategy tailored to Australia’s TGA framework.
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 publications to secure TGA approval for a 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 with no therapeutic equivalent. We coordinated all TGA and specialist communications to ensure market continuity and avoid disruption to patient care.
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