Your partner in quality
This project reminded me why risk-based thinking is so powerful. Instead of drowning in endless data, we focused on what truly mattered: the parameters that directly influence process stability and product quality. That change in perspective made everything easier. Testing became leaner, documentation clearer, and the entire process more controlled. We didn’t take shortcuts — … Read more
Scaling up a manufacturing process always feels like crossing a bridge — between what you already know works and what you’re about to prove on a bigger stage. It’s a process that combines science, teamwork, and a healthy amount of patience. Our recent validation focused on confirming that the process we’ve already qualified can perform … Read more
Australia has become a leading destination for early-phase and investigator-led clinical trials — thanks to its strong regulatory framework, skilled researchers, and efficient ethics approval processes. However, to conduct a clinical trial successfully, sponsors must understand their responsibilities, key stakeholders, and the pathways available through the Therapeutic Goods Administration (TGA). 1. Setting the Foundation for … Read more
Investigator’s Brochure (IB) is one of the critical documents included in the HREC submission package to support the conduct of a clinical trial. As the name suggests, its purpose is to provide investigators with the basic and most up-to-date scientific information on the Investigational Product (IP), including the type and severity of potential adverse reactions … Read more
GCP Inspection Program was introduced by TGA in 2022 with objective to straighten the TGA’s monitoring activities and protect the safety and well-being of the clinical trial participants participating in phase 1 to 3 clinical trials. The program not only ensures compliance with regulatory and ethical requirements (Therapeutic Goods Act 1989, Therapeutic Goods Regulation 1990, … Read more
Sil Pharma Pty Ltd
604, 30 Tank Street
Brisbane City, 4000
Queensland, Australia