@article{Patel_Badjatya_Patel_2017, title={PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION}, volume={5}, url={https://ijdra.com/index.php/journal/article/view/196}, DOI={10.22270/ijdra.v5i2.196}, abstractNote={<p>The present article summarizes &amp; simplify the marketing application requirements i.e. the critical aspects of<br>marketing application in different CTD using countries, Process to prepare and review the requirements for CMC<br>section (Chemistry manufacturing &amp; Control) for filing an application in regulated market. Study shows the<br>compilation of dossier as per CTD format with minimum errors during filing. The focus is on the application filing &amp;<br>Query part that may come after submission &amp; during approval process. So one has to focus on the requirements of<br>dossiers with minimal queries &amp; study the probable queries that may arise after filing an application to regulated<br>countries. Once approved, the applicant can market the safe, effective, stable &amp; quality generic drug product with low<br>cost to the public. The complete marketing application is based as per CTD format gives understanding of critical<br>aspects of Marketing Application and better understanding of dossier filing.<br>&nbsp;</p&gt;}, number={2}, journal={International Journal of Drug Regulatory Affairs}, author={Patel, Dhruvi H. and Badjatya, Jitendra Kumar and Patel, Amit A}, year={2017}, month={Jun.}, pages={1-12} }