Do you have therapeutic products? Are you wanting to know how to get TGA approval for your product or quality system?
All therapeutic products must be listed or registered with the TGA before it can be sold in Australia. Failure to do so is an offence.
Therapeutic products must also be manufactured by a TGA licensed manufacturer in Australia or an overseas manufacturer with TGA’s GMP Clearance.
We can assist companies to obtain TGA manufacturing license and GMP Clearance where required.
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 to successfully obtain TGA manufacturing license. The procedures and documents that we provide are the result of many TGA inspection experiences. We can coach your team on what are the best practices before, during and after a TGA inspection. One of our client did not get any major findings in the first TGA inspection. This allowed them to get the license quickly and start selling their product without further delay.
Please contact us if you have specific requirements not listed here.
Contact number: +613 8761924