CTD (Common Technical Document) for a Topical Preparation

A

aamani

Hi every one
I am going to write a CTD for a topical preparation. I have gone though the guidelines but was wondering if any one knows any forum which focuses on how to write CTDs.
Or if any one know any sample/example of a proper CTD.
All the best
 
V

v9991

Trusted Information Resource
considering the wide scope of the contents of CTD., note sure to find single reference/source., for same.,
but, i would start...with following references.,
1. FDA guidance document on various products. + references of the SBOA of products.,
2. QOS references and other documents outlined.
3. other general forums of CTDs.

and further, here's what i found on net.,

https://ec.europa.eu/health/sites/h...alex/vol-2/b/update_200805/ctd_05-2008_en.pdf

https://www.pharmatutor.org/pdf_dow...ue 10, October 2017, PharmaTutor, Paper-1.pdf

DIA - Regulatory

Regulatory Affairs CTD/ e -ctd Expert Fresher and Experienced
:2cents:
 
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