by Dr. Yashashwini Reddy | Sep 29, 2024
“Essential Regulatory Affairs Interview Questions for Freshers in Pharma: Tips & Answers” 1. What is an Abbreviated New Drug Application (ANDA)? Answer: An Abbreviated New Drug Application (ANDA) is a regulatory submission to gain approval for a...
by Dr. Yashashwini Reddy | Sep 19, 2024
Japan Regulatory Authorities for Drug Approval: A Comprehensive Overview Navigating the complex landscape of drug approval in Japan requires a keen understanding of its regulatory authorities and processes. Japan’s commitment to ensuring the safety and efficacy...
by Dr. Yashashwini Reddy | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
by Dr. Yashashwini Reddy | Jun 8, 2024
A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...
by Dr. Yashashwini Reddy | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
