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Australian electronic Submission Basics Guide- Australia (TGA)
eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...

Sharan Murugan
Jun 27, 20211 min read
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Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...

Sharan Murugan
Jun 27, 20211 min read
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Submitting data in the eCTD format - Therapeutic Goods Administration - Australia
This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for...

Sharan Murugan
Apr 10, 20211 min read
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