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All your eCTD and Regulatory questions are answered! Check it out: www.onixls.com/faq/ Did we leave any questions unanswered?
Do you need eCTD submissions compiled with a quick turnaround? Send us your documents in an email or by secure File Transfer Protocol. We will compile the submission in the relevant format, provide it back...
Top 7 Questions to Ask Yourself Before Submitting That eCTD Application Working in an eCTD consultancy is probably the best place to see a wide variety of quick mistakes and rather large faux pas from...
This is what we do and how we do it! The first step is to send us your documents via secure FTP (or by email). We would then complete word formatting and PDF publishing if...
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eSubmissions (eCTD) The 1st DADI newsletter has been published on the EMA website The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of...
EMA News and press releases: Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
EMA News and press releases: EMA launches pilot project on analysis of raw data from clinical trials Other: Information about the raw data proof-of-concept pilot for industry eSubmissions (eCTD) DADI eAF Portal Guide to Registration now available The Digital Application Dataset Integration...
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