Speaking to Outsourcing-Pharma at DIA EuroMeeting in Monaco Kate Wilber, director of European regulatory services at Image Solutions (ISI), said that while electronic submission can save time and money, there are hurdles to be overcome.
Wilber explained that regional variations, difficulties in translating English eCTD documents into other languages and the complexity of European non-eCTD electronic submissions (NeeS) can cause problems.
She added that rejection of improperly formatted electronic submissions can generate a considerable amount of bad press before reviewers have even had the chance to examine the data contained within.