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Paper Details

COMPARITIVE STUDY OF DOSSIER SUBMISSION PROCESS FOR DRUG PRODUCT IN USA, EU & INDIAN REGULATORY

Swapna.G*, Bindhu Madhavi .Ch, Anusha.P, Rupa.T, Mohini.D, Venkkana.B

Journal Title:World Journal of Pharmaceutical Research
Abstract


In this presentation we did individually study about the rule & regulations1 which are followed for drug approval 2process in USA, Europe & India. Data 3 in the dossier 4 gives the answer of following questions: What is the product? Is the quality 5 presented acceptable on grounds of Safety 6 and efficacy? Is the quality 7 presented reproducible? How long can the quality be maintained 8 ? Quality must ensure consistency of safety and efficacy during the shelf life 9 of all batches Produced. And in last we did the comparative 10study. This comparative study of dossier compilation given a brief idea about the difference in regulatory requirements 11 for drug approval process among USA, EU & India.

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