HSE Food Safety Consultants are experienced advisors that can assess your products intended for sale in Australia to advise in report form how to proceed with your application to the Therapeutic Goods Administration (TGA), as per the most current scientific advice and legal requirements.
Should your manufacturing plant be located outside of, or within, Australia and you seek to sell complimentary medicines, prescription and over the counter etc., then there is a set out procedure required to be completed and approved by the TGA with their associated fees. HSE can assist with the pathway that your company must take in order to have the TGA approve your operations.
HSE will assess each product that you intend to sell in Australia and confirm that the product will be approved by the TGA.
The decision taken by the TGA to perform their own on site assessment which results in high fees ($1300 per hour +flights and accommodation) is normally as a result of a poor/ substandard application made where the applicant is not suitably prepared to submit an application and has done so in any case. In most cases these high costs can be avoided when managed correctly. HSE will guide you through the process and determine the likely pathway to approval.
HSE will be happy to take your call and or enquiry.