Our preliminary meeting will form the basis of the regulatory strategy moving forward.
We are most flexible with the initial discussions either by phone conference, at your facility or at our premises.
We will share with you the regulatory landscape for similar products in Australia and will work with you on the most strategic tactical approach for a timely product approval.
We will give you the choice to either ask the right questions to your manufacturer with regards to key product information required for the submission to the Therapeutic Goods Administration or you can leave it to us for total coordination.
You will be given the option of accessibility to our secure website portal for live and up to date project updates.
Our differentiated approach will allow you to download information directly to the secure and company specific portal for our assessment and feedback.
Our e-document system will allow you to retrieve information at most times at a click of one button. Auto monthly reports to your management format can be produced and auto sent to you pursuant to your requirements.
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