Do you have therapeutic products? Do you need a TGA GMP licence for your site?

All Therapeutic products must be listed or registered with the TGA Failure to do so is an offence.
TGA’s GMP licence is required to manufacture therapeutic products.

We can assist companies to get TGA’s GMP license.

Services we offer:

• Provide full turnkey support in obtaining TGA Manufacturing License
• Assistance in preparing for TGA inspections and support with post TGA inspections response
• Assess company readiness for TGA audit
• Provide Regulatory Affairs services for medicines and medical device class 1
• Source TGA approved contract manufacturers in Australia. These are manufacturers that have TGA Manufacturing License.

Why select us?

We have assisted various organizations in obtaining TGA manufacturing licenses successfully. We can coach your team on the best practices before, during and after a TGA inspection. The procedures and documents that we provide result from many TGA inspection experiences. One of our clients did not get any major findings in the first TGA inspection. This allowed them to get the license quickly and sell their product without further delay.

Please contact us if you have specific requirements not listed here.

Email: lky@australiaquality.com.au
Contact number: +613 8761924