ctdquality.blogspot.com

CTD Quality Consulting

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information.

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CTD Quality Consulting | ctdquality.blogspot.com Reviews

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This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information.

<META> KEYWORDS

1 ctd quality consulting

2 annotated ectd templates

3 posted by

4 no comments

5 labels cmc documents

6 see separate article

7 submission ready documents

8 o characterization

9 o formulation development

10 o manufacturing development

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ctd quality consulting,annotated ectd templates,posted by,no comments,labels cmc documents,see separate article,submission ready documents,o characterization,o formulation development,o manufacturing development,o method validation,o process validation

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CTD Quality Consulting | ctdquality.blogspot.com Reviews

https://ctdquality.blogspot.com

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information.

INTERNAL PAGES

ctdquality.blogspot.com

1

CTD Quality Consulting: Annotated eCTD Templates

http://ctdquality.blogspot.com/2009/12/annotated-ectd-templates.html

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information. Wednesday, December 30, 2009. 8226; Instructions to put hyperlinks in blue text, s...

2

CTD Quality Consulting: CTD Mapping and the eCTD TOC

http://ctdquality.blogspot.com/2009/12/ctd-mapping-and-ectd-toc.html

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information. Wednesday, December 30, 2009. CTD Mapping and the eCTD TOC. 7 Timing of draft 1, d...

3

CTD Quality Consulting: Submission-Ready Documents

http://ctdquality.blogspot.com/2009/12/submission-ready-documents.html

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information. Wednesday, December 30, 2009. Documents may be written in early development in an ...

4

CTD Quality Consulting: Efficient Creation of CMC Submission Documents

http://ctdquality.blogspot.com/2009/12/efficient-creation-of-cmc-submission.html

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information. Wednesday, December 30, 2009. Efficient Creation of CMC Submission Documents.

5

CTD Quality Consulting: December 2009

http://ctdquality.blogspot.com/2009_12_01_archive.html

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information. Wednesday, December 30, 2009. 8226; Instructions to put hyperlinks in blue text, s...

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ctdquality.blogspot.com

CTD Quality Consulting

This blog is created by Dr. Michelle Herrera Foster of CTD Quality Consulting. The writings in this blog summarize tools and processes for more efficient preparation of regulatory strategy and submissions, transition to eCTD and global harmonization. Dr. Foster has 20 yrs experience in the pharmaceutical industry and teaches internationally on CTD/eCTD submissions and processes. See www.ctdquality.com for more information. Wednesday, December 30, 2009. 8226; Instructions to put hyperlinks in blue text, s...

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