Hi Kristen,
They are several providers of eCTD solution, 1 question to consider: do you intend to publish only INDs ? and how many do you plan to publish per year?
You have also to consider probably to get an eCTD viewer in addition to publishing tool: you will find a lot of integrated eCTD solutions just doing some quick search with internet browser. Most important all documents to be added for a publishing eCTD sequences have dedicated format rules and should be PDF format. We have a complex publishing tool in my company because we do publishing for all eCTD countries and also for non eCTD countries (pCTD & NeeS format). Last point to consider: do you buy the tool or do you pay annual fee to use a dedicated eCTD solution? lastly do not forget to consider support (assistance) aspect from the provider of eCTD solution tool it's critical. Last you have also to consider IT aspect how do you store your documents? how do you store your eCTD INDs?
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Alberto Perfeito
Head of Portfolio and Partner Management
Sanofi R&D
Chilly-Mazarin
France
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Original Message:
Sent: 11-Jan-2024 10:27
From: Kristen Herzegh
Subject: eCTD Platforms
Hello, The university I work for is exploring eCTD platforms. I'm hoping to gather feedback on companies you've used and would recommend (or not). For context, all submissions will be research INDs. Thank you for your feedback.
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Kristen Herzegh, MPH, RAC
Atlanta, GA
United States
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