by Naveen kumar | Nov 24, 2024
Career Opportunities in Project Management for the Pharmaceutical Industry The pharmaceutical industry offers exciting career prospects for individuals interested in project management. As the industry continues to grow and innovate, skilled project managers are in...
by Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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...
