Author Archives: Caroline Andersson

TGA now accepting eCTD submissions

Posted on June 4, 2015 by Caroline Andersson

The TGA have now started accepting applications from the pharmaceutical industry in the format of electronic Common Technical Documents (eCTD). After their initial pilot program, they have an updated the version of the Australian eCTD Module 1 and Regional Specification – … Continue reading →

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FDA move to only accept eSubmissions

Posted on May 21, 2015 by Caroline Andersson

With the progress of technology we are bit by bit transitioning to working paperlessly in a range of different industries. In the pharmaceutical industry, this has been evident since 2003 when the US Food and Drug Administration (FDA) started accepting … Continue reading →

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Debenu PDF Aerialist Pharma and ARCS Sydney 2015

Posted on April 29, 2015 by Caroline Andersson

For anyone in Pharma/Healthcare that isn’t aware, the Therapeutic Goods Administration (TGA) in Australia is moving forwards with the use of submissions in the Electronic Common Technical Document (eCTD) format, with the aim of accepting eCTD submissions in June 2015. … Continue reading →

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