With a wealth of experience in the pharmaceutical industry, we have successfully guided numerous clients through complex regulatory landscapes, ensuring compliance and driving impactful outcomes. Our strategic approach and dedication to client success set us apart as a trusted partner in achieving regulatory and operational excellence.
Our Proven Track Record
Before diving into the specifics of our previous projects, it’s important to highlight our commitment to excellence and our ability to deliver measurable results.
Designing and mobilizing the solids manufacturing department in a clinical trial manufacturing facility – BioSA, Adelaide
Designing and mobilizing the solids manufacturing department in a clinical trial manufacturing facility – BioSA, Adelaide
Designing and mobilizing the solids manufacturing department in a clinical trial manufacturing facility – BioSA, Adelaide
Application for and acquisition of a TGA manufacturing license in a clinical trial manufacturing facility – Port Melbourne, Melbourne
Designing and mobilizing the solids manufacturing department in a clinical trial manufacturing facility – Port Melbourne, Melbourne
Gap analysis and consulting services for a TGA manufacturing project consisting of clean rooms, HVAC, production machinery, and equipment layout – Nowra, NSW
Preparing the Validation Master Plan and implementing required validation for a new facility (HVAC, Cleaning, process validation IQ, OQ, and drafting the PQ for equipment) – Minto, Sydney
Establishing a full QMS system and related documentation for a brand-new pharmaceutical facility – Thornleigh, Sydney
Application for and acquisition of packaging and manufacturing TGA licenses for a pharmaceutical facility – Thornleigh, Sydney