[ 08 · TOWARD SUBMISSION ]
Staying submission-ready instead of assembling at the end
“Everyone describes the submission as a huge push at the end. Is there a way to avoid that?”
The end-of-programme scramble is not caused by volume; it is caused by archaeology. Teams spend the final months reconstructing decisions made years earlier by people who have left, from records made for a different purpose. Readiness is a property of how the record was kept, not of how hard the last quarter is worked.
WHAT THIS IS NOT
Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.
ARE YOU HERE?
- The submission is far enough away that preparing for it feels premature
- Decisions are being made in meetings and captured in whatever the meeting produced
- Nobody could currently answer "why is this parameter set here?" without asking a specific person
WHAT TO DECIDE NOW
- The structure the eventual submission takes, so evidence is filed into it as it is generated rather than sorted into it later
- Who is accountable for the record being reconstructable, as an explicit responsibility rather than an assumed one
- What "done" means for a decision — a decision recorded with its rationale, not a decision taken
START KEEPING THESE RECORDS NOW
- Rationale alongside every significant decision, dated and attributable. This is the whole of the difference between assembly and archaeology.
- The link from each result to the requirement it satisfies, maintained as you go rather than mapped retrospectively
- Superseded versions and the reason for supersession, because a reviewer’s question is often about the version you no longer use
PUT IT TO WORK
SPEQ templates and tools for the work above. They structure it; they do not decide it for you.
- TEMPLATE · RECORDIND Application Assembly Record →For a drug, the structure evidence is filed into as it is generated rather than sorted into at the end.
- TEMPLATE · RISK ASSESSMENTData Integrity (ALCOA+) Assessment →Check that the records you are relying on can be reconstructed, system by system.
- TOOL · ~6 MINEvidence Health & Readiness Score →Score readiness from evidence status, where missing never counts as compliant.
THE PROBLEM THIS ANSWERS
A submission is assembled at the end from records that were never filed against the structure they would eventually need, so preparation becomes an excavation of the organisation’s own history.
What it costs: Months of calendar time spent locating and reconciling evidence that existed all along, at exactly the point when the timeline is least able to absorb it.
WHERE THIS GOES WRONG
- Deferring documentation until the science settles. The science never fully settles, and the undocumented interval keeps growing.
- Keeping the rationale in email. It is a record, it is discoverable, and it is nearly impossible to assemble into an argument later.
- Assuming the people present will still be present. In a small company over a five-year programme they generally are not.
WHAT THIS DOES NOT ANSWER
- Which submission format and modules apply, which follows from product type and jurisdiction
- Whether a rolling or staged submission is available to you, which is programme-specific
OFFICIAL SOURCES · INDEPENDENT THIRD PARTIES
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