We in regulatory affairs are passionate about systems and publishing tools, and regulatory authorities are no different. However, when these tools or the IT systems supporting them go down, everything comes to a standstill.
When the business demands an urgent submission during such downtime, the usual response is, “We can’t.”
Recently, one of our clients faced this exact issue: their IT system was down, and they had an urgent submission to make. They turned to us, knowing our innovative approach to problem-solving.
We kept it simple. We asked them to send us the package via email. Instead of trying to publish all the previous sequences on our tool (which the client couldn’t retrieve due to their IT issues), we contacted our contacts within the regulatory agency. We explained the situation and requested that they assess the submission via email, with the understanding that we would resubmit through the eCTD and standard channels once our client’s IT system was restored.
It took a bit of convincing, but they accepted the submission and began the assessment.
The moral of the story is to always challenge yourself in regulatory affairs. If you’re a stakeholder, challenge your regulatory colleagues to find alternative solutions when the usual ones aren’t working.