by Naveen kumar | Jul 1, 2024
A product needs to be tested and proven for its quality and compliance requirements before it reaches the factory to the consumer. With the increasing complexity of the equipment being manufactured as per consumer demand, there is a chance for countless errors. So,...
by Naveen kumar | Jun 30, 2024
Computer system validation, if you are thinking about starting your career in CSV, then this article will give you an overview of what CSV is, and what is the role of CSV in the Pharma industry. CSV is a critical requirement of regulatory agencies. It aims to ensure...
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 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...
