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’s new drug approval process is managed by the Pharmaceuticals and Medical Devices Agency (PMDA), which works under the Ministry of Health, Labour, and Welfare (MHLW). Here’s an overview of how a drug gets approved in Japan: 1. Preclinical Testing...
by Naveen kumar | Jun 25, 2024
An abbreviated new drug application is submitted to the FDA Office of Generic Drugs. let us learn about generic drug products before the ANDA application Process. A Generic drug product is comparable to the innovator in terms of strength, dosage form, route of...
by Naveen kumar | Jun 25, 2024
While learning regulatory affairs there are several abbreviations you come across, you usually end up searching for them. Here is a list of abbreviations that are commonly repeated. There are several topics related to regulatory affairs where you come across these...
by Naveen kumar | 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...
