by Naveen kumar | Jul 11, 2024
Water is a major requirement for the pharmaceutical industry. We cannot imagine life without water and even in pharmaceutical manufacturing water is one of the most important requirements and based on the regulatory requirements the standards for water are...
by Naveen kumar | Jul 8, 2024
Intellectual Property rights department is one of the good careers, especially in the pharma industry it plays a crucial role. If you want to start your career in the pharma industry, this article will help you understand IPR in Pharma. Intellectual Property rights...
by Naveen kumar | Jul 2, 2024
What is an Audit trail? In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic...
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...
