It’s Official – Good Manufacturing Practice (GMP) licensed
We are incredibly proud to share that PharmSky has officially been granted its Good Manufacturing Practice (GMP) manufacturing license by the Therapeutic Goods Administration (TGA).
This milestone marks a significant leap forward in our mission to support the Australian clinical trial ecosystem. With this license, PharmSky is now authorised to manufacture clinical trial materials for Phase I, II, and III studies, enabling us to support our clients through later-stage development with full regulatory compliance and technical excellence.
This achievement reflects the unwavering dedication, professionalism, and teamwork of every member of the PharmSky team. From our formulation scientists and analytical chemists to our QA, operations, and project management teams. Every person has played a vital role in reaching this point. This license is a direct result of your hard work, and we could not be prouder.
Independent CDMO offering end-to-end development and clinical manufacturing services
The TGA GMP certification confirms the quality and rigour of the systems we’ve built and firmly establishes PharmSky as one of Australia’s few fully independent CDMOs offering end-to-end development and clinical manufacturing services under one roof. From early-stage development to packaging, stability, and now late-phase clinical supply, we are positioned to be a long-term partner for pharmaceutical and biotech innovators.
As we continue to grow, this milestone unlocks exciting new opportunities, not just for us, but for the clients and patients we serve.
To our clients, collaborators, supporters and most importantly, our exceptional team — thank you. This moment belongs to all of us.
Onward and upward.
– The PharmSky Team
