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Take the next step forward. ECTD Software and Tools. The electronic common technical document. While both the FDA and ICH offer several guidance documents intended to facilitate the transition to eCTD submissions, these resources fail to address many important considerations:. What eCTD regulatory software and tools will your company require, and which software provider(s) can offer a package that suits your needs? Courses are most effective for your esubmissions? Or regulatory submission assistance?
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eCTD Tips – Tips, advice, and news about regulatory submissions in eCTD format.
Transitioning from Paper to eCTD. 10 August 2017 By Evan Richardson. In Tips and Advice. In 2011, I wrote a guest post over at The eCTD Summit about transitioning from paper to eCTD submissions. Surprisingly, much of the advice in that post 6 years ago is still applicable, but the process is even easier today. FDA’s deadline for converting marketing applications. Answers to Your eCTD Questions. 28 July 2017 By Evan Richardson. In Tips and Advice. New Technical Rejection Criteria for Study Data. Scanned d...
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