Pharmaceutical

Industry Pharmaceutical Regulation

How ICH Guideline Topics Are Named And Categorized?

If you are new to the regulatory guidance, even some peers in the regulated field for a while, it is still quite unclear what are the M10, S6, R2 means in ICH guidelines. So this article...

Chemical Pharmaceutical Regulation

What are Nitrosamine Impurities in Drugs

Nitrosamine, formally known as N-nitrosoamine, is a class of organic molecules with the above core structure. These type of chemicals are believed carcinogenic due to their potential as alylating reagents inside cells, which will cause cancer....

Pharmaceutical Regulation

A Quick Guide for IND Application

How many types of FDA IND application? There are multiple types of IND application. Generally, your IND will be either 1) commercial or 2) research. It depends on whether it will be used to support marketing application afterwards. There are then three...

Pharmaceutical Regulation

A Quick Guide to FDA pre IND Meeting

What is a pre IND meeting with FDA? Pre IND meeting with FDA is an important step of IND application. An IND application is (a) sponsor(s) that submit the product’s data and information to FDA (Food...