Listing Applications – a requirement for medicine listing applications is that there is suitable evidence available to support the claims being made and that evidence needs to be presented in a suitable evidence summary. Regulatory Concepts can assist you in many ways according to your budget. We can review your evidence and/or evidence summary and provide comments as to their acceptability; We can assess your evidence and create the evidence summary; or the ultimate we can search for evidence and create the evidence summary.
TGA has many guidance notes to help determine what evidence is appropriate and how it should be summarised.
Regulatory Concepts has the experience to review evidence and put together the appropriate evidence summary. In particular we have built up a special library for essential oils so we can provide you with ready made evidence packages that can easily be combined or adjusted according to your specific product formulation. This takes out the long time frame and costs which would be normally associated with having to prepare such evidence from scratch.
- Evidence Summary
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TGA has many guidance notes to help determine what evidence is appropriate and how it should be summarised.
Regulatory Concepts has the experience to review evidence and put together the appropriate evidence summary. In particular we have built up a special library for essential oils so we can provide you with ready made evidence packages that can easily be combined or adjusted according to your specific product formulation. This takes out the long time frame and costs which would be normally associated with having to prepare such evidence from scratch.