suvra jyoti dutta


{ City } paonta sahib
< Country > india
* Profession * sr. executive regulatory affai
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Question { 5468 }

what is dossiar ? How can I submit to the regulatory
department ?


Answer

Dossier is a file document submitted for the approval of
drug product.It is submitted in form of CTD to the
regulatory agency. CTD is a harmonized format (template)
for presenting data in the ICH regions.

Is This Answer Correct ?    4 Yes 0 No