In Australia, especially for therapeutic goods and foods, it is generally very difficult to take a  label that is universally accepted in most countries and gain approval without changes. Australian labelling rules are very particular especially with respect to medicines, and for OTC medicine and foods, the label content is also  very closely linked to advertising plans. If you are planning a world wide launch, we can help review your labels to ensure that the Australian specific requirements are maintained while still achieving a globally acceptable presentation of your labelling.

The labelling rules in Australia for medicines are complex as they require reference to more than one guideline – We have developed checklists to ensure that we cover all the necessary guidance rules that need to be taken into account. We look at your labels from both the regulatory and marketing aspects and will give you workable options to consider.

For Listed medicines we ensure that your label statements are in line with your available evidence summary.

Regulatory Concepts can provide its services for the  complete process of artwork approval – from the time labels or other  printable documents, such as PI’s and CMI’s, receive official TGA approval through to the final stage of signing off final ARTWORK copy before it goes to print. Using the ADOBE® software applications which enable electronic signatures and approval stamps we can provide this crucial service as part of your Australian regulatory office support.

Label updates can occur for many reasons-such as internal  quality or company policy changes; changes to TGA or Medsafe guidelines; transfers from another company- Regulatory Concepts personnel have the experience and eye for detail and with the use of our internal checklist and qc process, we can review labels and provide recommendation of changes required to meet the latest  guidelines. The product range covered includes medicines/medical devices/foods/cosmetics.

Artwork Review & Sign Off

Regulatory Concepts can provide its services for the  complete process of artwork approval – from the time labels or other  printable documents, such as PI’s and CMI’s, receive official TGA approval through to the final stage of signing off final ARTWORK copy before it goes to print. Using the ADOBE® software applications which enable electronic signatures and approval stamps we can provide this crucial service as part of your Australian regulatory office support.

Label Update Review

Label updates can occur for many reasons-such as internal  quality or company policy changes; changes to TGA or Medsafe guidelines; transfers from another company- Regulatory Concepts personnel have the experience and eye for detail and with the use of our internal checklist and qc process, we can review labels and provide recommendation of changes required to meet the latest  guidelines. The product range covered includes medicines/medical devices/foods/cosmetics.

Regulatory Concepts

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