Notes on Indian regulatory practice, written for people who have to file.
We are writing up the questions clients ask most: when Indian clinical data is genuinely required, how to sequence Ethics Committee, CTRI and CDSCO steps without stalling, and what a Subject Expert Committee actually wants to see.
Tell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
Talk to our regulatory team