Medicinal products, including listed products (AUST L) manufactured in Australia, must be manufactured at TGA licensed facility that meets the PIC/S standard for Good Manufacturing Practice (GMP).
Our GMP consultants are experienced with the PIC/S GMP and can assist with obtaining a TGA manufacturing license.
We can also assist with the design of the facility, and connect you with the right expertise for factory construction.
Depending on what stage your project is at, our GMP consultants can come in and assist with project management and designing a plan for implementing the right QMS for obtaining a TGA manufacturing license.
Whether your product is a capsule, liquids, oral/topical, sterile/non-sterile, we can assist with designing the right PQS/QMS that meets TGA requirements.
PQS documentation is our expertise including validations, risk management, change management systems, corrective actions etc. We can also design and implement appropriate training management plan for all personnel.
We also provide ongoing ad hoc services and training if needed even after the TGA manufacturing License is granted.
