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 12, 2024
Once we submit the IND application, how the FDA reviews the application and what acknowledgment letter is given after the IND submission all will be discussed here. IND is an application submitted to the FDA to conduct clinical investigations in humans, once the...
by Naveen kumar | Jun 10, 2024
Methods in Pharmacovigilance, this article will give you an overview of the pharmacovigilance methods and the concepts involved in it. Definition of Pharmacovigilance as per WHO: science and activities relating to detecting, assessing, understanding, and preventing...
by Naveen kumar | Jun 4, 2024
Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...
by Naveen kumar | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
