From compliance to competitive advantage: closing the regulatory IM knowledge gap
This article was originally published in SRA
Executive Summary
The life sciences industry has never been under greater pressure to record and monitor critical information about its product and licence life-cycles. Failure to put this painstakingly captured knowledge to good commercial use is a great waste, says Adam Sherlock.
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Taking On the World: One Size Does Not Fit All
Simultaneous multimarket entry is a growing reality for the pharmaceutical industry as regulatory agencies worldwide move to further standardise the format and structure for submissions. Growing acceptance of the electronic common technical document (eCTD) standard for submissions is paving the way for standardisation and greater efficiencies, certainly, but there is still some way to go.