Introduction to Regulatory Buddy

Drug development is a technically deep field with so many moving parts. Regulatory Affairs is like a Core that holds all these parts together and liaise between the sponsor (or a company developing the drug) and Regulatory Agencies (Eg: FDA in US; MHRA in UK) to protect the health of public by providing safe and efficacious drugs.

Regulatory affairs professionals are involved in reading a lot: Regulations, laws, guidance documents etc. A lot of patience is required to read and understand all these documents. Even after putting those long hours of reading, you may forget it next time when you need it because Regulatory Affairs is too dry of a subject to stick. Of course, things do tend to stick as you read/do them again and again. But, to keep up with huge volumes of guidance documents is a gigantic task.

I am relatively young in this Regulatory field as of this writing and have about 12 years of experience between academia and Industry before joining regulatory. One way to grow in the regulatory is by doing a lot of reading and use it whenever necessary. Similarly, Few ways to learn anything quickly or get what you learned to stick is by teaching it to others or by writing them down in your own words and that is what I am trying to do at Regulatory Buddy. Why not articulate whatever I am reading so that it sticks to me and may help others. And hence this publication or blog.

My idea is to give following perspectives to different guidance document or articles so that it is easy for a reader to understand: Why, When, Who, Where and How. But then, different documents are different and I highly doubt if one size will fit all. So, I will tailor as needed as I travel along. I am still learning and will always do.