About Us

As the name suggests, this blog is about drug regulatory guidelines of API (active pharmaceutical ingredient) of pharmaceutical sector. Various health and drug regulatory organizations over the world have set guidelines to facilitate safe and effective medicines for human and veterinary consumption. Guidelines set by ICH (International Council of Harmonisation) are one of the most accepted guidelines worldwide. Also there are country specific guidelines set, which are suitable as per country’s climatic zone. “API regulatory guidelines BlogSpot” focuses only on API related regulatory guidelines. Articles posted in this blog are summary of already published guidelines. An attempt is made to simplify and elaborate guidelines without changing actual objective of guidelines by explaining in form of flow chart, presenting data in tabular form, providing examples, etc. Link of specific guideline and its reference is mentioned in applicable posts. Below is contact details of author:

Name: Dundappa B. Kalashetty

e-mail id: kalashettydb@gmail.com