Hold onto your hats because we’ve got a story to tell! Our client’s quality department went on a wild adventure through compliance land, comparing their QC specs and analytical methods to what’s written in the license. Buckle up, because they found more twists and turns than a rollercoaster.
Our client’s Quality Director had batches to release but hit a roadblock because of these discrepancies. She asked about the approval date of a variation and its implementation date. But hold the phone – that’s the wrong question!
They’ve been releasing this product for ages, and all the confusion boils down to one single variation approval. We asked a more precise question – which registered documents your quality team used for compliance checks. You won’t believe it, but they picked the wrong one, thinking it was the registered version. The result? Discrepancies galore!
We handed them the real deal, and like magic, the discrepancies vanished into thin air. Lesson learned – the right question is your ticket to the right answer.
And if you’ve ever found yourself asking the wrong question, don’t sweat it. Just pivot, ask the right one, and watch the magic happen.
If you wish to ask either the right or the wrong question in order to obtain the correct answer, please go ahead and book the call below so that we can discuss your current regulatory matter.
“Accelerated Regulatory Action Call.”
Best regards,
Aziz