Complimentary Medicines
In Australia complementary healthcare products are classed as medicines and must be listed or registered on the Australian Register of Therapeutic Goods (ARTG) through the Therapeutic Goods Administration (TGA). We can facilitate all aspects of this process by providing the following specialist services:
Claims formulation and substantiation
Listed medicine applications
Evidence packages
Label development and reviews
Advertising reviews
GMP pre clearance for overseas manufacturers
Review of product specs and documentation's
Response to section 31, request for information from the TGA
CMEC applications
Proprietary ingredient notifications
Liasing with the TGA
We can also assist in addressing other issues that may arise during the process of bringing a product to market, and during post market monitoring.
Product Research & Development
Technical Writing and Advertising Material
E-mail: rachael@rkeenanconsult.com.au