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Advances in Applied and Pharmaceutical Sciences Journal 

ISSN 2457-0842

Abstract


Volume 1 Issue 1, July-August 2017, Pages:6-10


Authors: Syed Iftequar, M. Shahabuddin, Zahed Zaheer Nazim Chisti
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Abstract: The aim is to provide the basic information & understanding related to the types of regulatory submissions are in practice by pharmaceutical industries to commericalise drug product in market of perticular country. A regulatory submission includes any documentation or information submitted to a regulatory agency for review, of submitted information or in response to a request for additional information related to a healthcare product. The format for submission can be paper or electronic format like Electronic Common technical document (e-CTD) or can be filled using both way. Each regulatory agencey has its own set of rules and procedures which is important to comply and implement. Non compliance leads to the queries or refusal of submissions based on the type of problem Minor or major. FDA usually takes certain time to respond on submissions and asks submitter to reply on his queries within his required time frame. In this article different types of regulatory submissions are highlighetd with their steps
Cite this article: Syed Iftequar, M. Shahabuddin, Zahed Zaheer Nazim Chisti “ Types of Regulatory Submission : A Review“ Advances in Applied and Pharnaceutical Sciences Journal 2017, 1 (1);6-10