PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 2
Abstract
The present article summarizes & simplify the marketing application requirements i.e. the critical aspects of marketing application in different CTD using countries, Process to prepare and review the requirements for CMC section (Chemistry manufacturing & Control) for filing an application in regulated market. Study shows the compilation of dossier as per CTD format with minimum errors during filing. The focus is on the application filing & Query part that may come after submission & during approval process. So one has to focus on the requirements of dossiers with minimal queries & study the probable queries that may arise after filing an application to regulated countries. Once approved, the applicant can market the safe, effective, stable & quality generic drug product with low cost to the public. The complete marketing application is based as per CTD format gives understanding of critical aspects of Marketing Application and better understanding of dossier filing.
Authors and Affiliations
Dhruvi H. Patel, Jitendra Kumar Badjatya, Amit A Patel
Keywords
Related Articles
- EP ID EP326700
- DOI 10.22270/ijdra.v5i2.196
- Views 160
- Downloads 0
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