With Brexit looming large on the horizon, we were tasked with package preparation and submission in just six weeks – a very tight deadline that required our unique expertise.
The first challenge was the gap analysis for the M1 dossier: some documents had expired and/or contained incorrect information. A subsequent check of the M2, M3, M4 and M5 documents revealed certain issues. For example, whilst reviewing the M3 dossier, we realised some excipients tradenames were stated, and in order to prevent filing additional variations when those wanted to be changed, we recommended to remove the extra details from the dossier.
Further complicating the process was the fact some documents were not available at all, or at best delivered later during the package preparation. This added to the sense of urgency, as many documents in the later modules required changes (i.e. M3) before submission. The quick turnaround made open and responsive communication vital to success, but unfortunately an already tight schedule on the client-side made getting the answers we needed difficult, forcing us to accept that further delays were inevitable.