全部 标题 作者
关键词 摘要

OALib Journal期刊
ISSN: 2333-9721
费用:99美元

查看量下载量

PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION

DOI: 10.22270/ijdra.v5i2.196, PP. 1-12

Subject Areas: Drugs & Devices

Keywords: CTD, CMC, Module, ICH, Dossier, Active Pharmaceutical Ingredients (API), Certificate of Analysis (COA).

Full-Text   Cite this paper   Add to My Lib

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.

Cite this paper

Patel, D., Badjatya, J. and Patel., A. A. (2017). PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION. International Journal of Drug Regulatory Affairs, e8283. doi: http://dx.doi.org/10.22270/ijdra.v5i2.196.

Full-Text


comments powered by Disqus

Contact Us

service@oalib.com

QQ:3279437679

WhatsApp +8615387084133