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COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
2018
International Journal of Drug Regulatory Affairs
Preserved Fulltext
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.
doi:10.22270/ijdra.v2i2.125
fatcat:pfcaejzcd5dpded5zsz33rin4q