How This Engagement Runs
Life sciences
A submission window that will not move
What I sign up to hit
10 days
to a written answer on whether the date is still real
One
re-baseline, with the evidence behind it
The Challenge
The date belongs to the regulator, and nobody can see the whole package
- 1
A filing date set outside the organization, with penalties for missing it that are not commercial
- 2
Evidence assembled across three sites, each confident its own part is on track
- 3
No single view of what is actually missing, so the gap only appears when someone tries to compile
- 4
A plan that has been green for two quarters because nobody owns the word amber
My Approach
Find out what is true, then commit to one date
The first ten days
Diagnosis, not delivery. I go to the people doing the work rather than to the status deck, and I find out what is actually assembled and what is still a plan to assemble something.
One view of the package
I build a single list of what the submission requires and what exists today, at the level of the artifact rather than the workstream. Most of the surprise lives in the gap between those two.
A written answer on the date
Within ten days you get it in writing: the date is still real, or it is not. If it is not, you get that early enough to do something, which is the only time that answer is worth anything.
The honest re-baseline
One re-baseline, with the evidence behind it, defensible to the person who will ask why the first plan was wrong. Not three successive slips, each announced when the previous one became undeniable.
Evidence of closure
Every item closes against something a reviewer can read, not against someone's assertion that it is done. This is the part that is always underestimated and always on the critical path.
What survives me leaving
The rhythm that holds the package together gets trained into your team as we go. The next submission window should not need me.
The Targets
10 days
to a written answer on whether the date is still real
One
re-baseline, with the evidence behind it
Agreed with you before the work starts, and reported against weekly. These are commitments, not results from a past client.
My commitment
If the date cannot be made I will say so in writing, early, while there is still time to do something about it. That is the whole job.
Services Applied
Facing a similar challenge?
Every situation is different, but the failure patterns rhyme. Book a call and I'll tell you straight whether this is work I can help with.
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