Guide
Drug-device combination products: how India regulates them
A product that is part device and part medicine raises one question first: which rules apply? Here is how India answers it, and how the US and EU compare.
Insights
Pharmaceuticals insights
How do I get this study approved and run in India? Guides, updates and sourced facts for pharmaceuticals & clinical research, alongside our pharmaceuticals sector page.
Pharmaceuticals insights
Regulatory update
ICH E6(R3) is now final: what it means for trials in India
The new good clinical practice guideline is final. Here is what changed, how it reaches trials run in India, and the steps to take now.
Not sure which route applies to your product?
A Readiness Assessment confirms the regulatory route and the evidence it needs, before you commission testing against the wrong requirement.