COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 2
Abstract
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.
Authors and Affiliations
Mohidekar S, Maharao V, Badjatya J. K.
Keywords
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- EP ID EP345402
- DOI 10.22270/ijdra.v2i2.125
- Views 96
- Downloads 0
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