DRAP
The new article highlights the critical points related to the application process, outlining the key steps to be taken when applying for approval in a clinical investigation.
DRAP
The new article describes in detail the key responsibilities of the parties involved in clinical research.
DRAP
The article provides a general overview of Pakistan’s regulatory requirements for clinical research.
EU
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
FDA
The article provides a brief overview of the applicable regulatory requirements related to using real-world data in the context of submissions associated with medical devices intended to be marketed and used in the US.
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