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.
Insights
Regulatory updates
Changes to the rules, forms and guidance for regulated products in India and beyond: what changed, who it affects and what to do about it.
Regulatory updates
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.