Regulatory Affairs

Regulatory approval is required whenever a new therapeutic good or agricultural, veterinary or industrial chemical is to be introduced into Australia, whether by manufacture or importation. The regulations for the above mentioned products have been developed by different government agencies to ensure that these products and their manufacture, are of a high quality and that they are safe and effective when used as directed.

These regulations and their intricacies can often be overwhelming to those unfamiliar with the process. This may result in applications that are incomplete or not detailed enough, which is then costly, as the application is delayed or even rejected. By providing ChemSkill with the necessary information, our experienced Regulatory Affairs Consultants can assist you in the registration of chemicals and products with the following organisations:

* TGA - Therapeutic Goods Administration

* GMP - Good Manufacturing Practice

* APVMA - Australian Pesticides & Veterinary Medicines Authority (formerly NRA)

* NICNAS - National Industrial Chemical Notification Assessment Scheme

* FSANZ - Food Standards Australia New Zealand (formerly ANZFA)

* AQIS - Australian Quarantine Inspection Services