Medicines & Medical Device Regulatory Submissions
The objective of the TGA (Therapeutic Goods Administration) is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices.
Essentially therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. The ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or exported from, Australia.
TGA administers the legislation and requirements for inclusion of therapeutic goods in the ARTG, including scheduling, labelling and advertising. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.
De Groot Technical Services is able to advise on data requirements and assist in the preparation of medicine and medical device submissions and other TGA submissions.
De Groot Technical Services Pty Ltd
2 Pittwin Road North
Capalaba, Brisbane 4154
(corner of Pittwin Road North and Mt Cotton Road, directly opposite Bunnings Warehouse)
61 7 3390 8777
"Work closely with our clients to provide quality and valued outcomes within agreed time frames.
Strengthen our reputation for quality processes and services with our clients and the regulatory authorities."