How would you define a perfect regulatory submission? In a previous job I had there was a company Vice President who thought a perfect submission meant receiving zero questions from regulators. No—as any reasonable regulatory scientist knows, that’s an extremely rare occurrence. Reviewers demonstrate that they have done their job by asking questions of the sponsor; it’s like marking their territory. So, it is unusual to receive no questions at all. 

Here’s something to consider: it is possible that if you did not receive any questions, it might be because you overcommitted in the clinical and CMC sections of your submission. And these are commitments that you and your team would be responsible to maintain. 

So, what do I mean by the perfect submission? I believe it is a document that is clear and understandable and easy for the reviewer to read with a minimal number of mistakes. Every file is present in the eCTD backbone. Every link takes the reviewer to the right place and every number has been double-checked. A perfect submission.

How do you plan to get from the reports generated by your team and your contractors to such a submission? Do you have subject matter experts to turn those reports into submission-ready documents? Do you have someone with regulatory experience to review them? I can help both with the writing and review. Let’s talk about a perfect submission—yours.