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Preparation and Maintenance of the IND Application in eCTD Format

$497.00
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$497.00
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September 2008
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Whether you’re still filing IND submissions in paper, or have filed electronically for a while, you’ll value this just-published book from FDAnews. Author William Sietsema, drawing on his real-world experience with IND submissions — and adding real-world case studies from ZymoGenetics and Epix — offers ready-to-use, expert guidance on the content and structure of all the components of an IND in CTD format with the focus on electronic submissions. 

Order now for full life-cycle guidance on managing your IND submission, including:

  • Best practices for converting paper INDs into compliant eCTD submissions
  • The Structure of eCTD IND applications
  • How to evaluate an eCTD system
  • How to manage the life-cycle of eCTD INDs
  • Specific content and technical requirements of an IND in eCTD Format
  • How to transition an eCTD IND into an eCTD new drug application
  • How to avoid common (but costly!) errors with electronic submissions
  • Secrets for creating an effective eCTD culture
  • Choosing and using eCTD tools

You’ll discover exactly what’s required at every point in the IND lifecycle to properly submit your IND in eCTD format, avoid resubmissions and accelerate your time to market. And while other companies are struggling to make the transition, you’ll already have your systems in place.

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

Need Extra Print Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.

3-4 copies – 10%

5-6 copies – 15%

7-9 copies – 20%

10+ copies – 25%

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