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



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

Answer / suvra jyoti dutta

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

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