Open AccessCOMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
Author(s) -
S. Mohidekar,
V. Maharao,
Jitendra Kumar Badjatya
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i2.125
Subject(s) - drug development , business , drug , product (mathematics) , closure (psychology) , new product development , medicine , political science , pharmacology , law , marketing , geometry , mathematics
Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impurities in Drug substance and Drug product, Container-closure. Common deficiencies are presented in this article.
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