Regulatory approval for pharmaceutical products can be difficult to obtain, not least because the submission process is often slow and prone to errors. Thomas Svendsen and Peter Noes of NNIT tell World Pharmaceutical Frontiers how regulatory teams can use a business intelligence tool to monitor submission status and hasten time to market.
For many pharmaceutical companies, the process of regulatory submission is fraught with setbacks. Faced with a mass of data and no standardised means of tracking it, they are forced to use Excel or even Word-based tools to help prepare and finalise their submissions. And, because this work is performed manually, there is always the risk of making errors along the way.
"Before you actually make the submission, it’s quite difficult to get it all assembled and ensure that documents are signed and approved," says Thomas Svendsen, principal consultant at NNIT. "There are no standard systems as we know it, and we haven’t seen any that are able to track it convincingly."
For a smaller project this may not pose much of an issue but, when companies are dealing with a larger electronic common technical document (eCTD) submission, matters become more complex. It is not unusual to reach the end of the process and discover that certain documents haven’t been signed or even that they’ve been misplaced. This can lead to delays, which may affect time to market and damage the bottom line.