Regulatory Milestone and Capital Dependency Map
Set the next capital event and how far away it is. SPEQ returns the latest date each regulatory prerequisite can start, flags the ones whose start date has already passed, and names the longest outstanding lead time. Lead times are SPEQ planning estimates for a first-time programme, not regulatory review clocks.
OUTPUT
TIME
Limitations — read before you rely on this
- Lead times are SPEQ planning estimates for a first-time programme. They are not regulatory review clocks, not commitments by any authority, and not specific to any product — replace them with your own numbers wherever you have them.
- SPEQ is not a validated system, and nothing here is investment, legal or regulatory advice. Reproduce the plan in your own planning process before relying on it.
- The prerequisite sets are general. A particular investor, partner or acquirer will ask for things this map does not list, and may not ask for things it does.
- This map says nothing about whether a raise or a submission will succeed. It subtracts one plan from another and reports the sign.
WHAT THIS CALCULATES
The latest date each regulatory prerequisite can start if a capital event is to happen on its planned date, which of those start dates have already passed, and the longest outstanding lead time that sets the earliest achievable completion.
THE METHOD
startBy = monthsToEvent − leadTimeMonths ; earliest = max(leadTimeMonths across outstanding)- startBy
- Months from today by which the work must start to finish before the event. A negative value means the start date has already passed.
- monthsToEvent
- Months from today to the capital event — to when money must be committed, not to when the conversation opens.
- leadTimeMonths
- A SPEQ planning estimate of how long the prerequisite takes a first-time programme. Not a regulatory review clock and not a commitment by any authority.
- earliest
- The earliest month by which all outstanding work could complete if every outstanding item started now. Work in progress is counted at its full estimate, so this is the conservative end.
- outstanding
- Prerequisites not marked done.
The arithmetic is deliberately trivial. The value is in holding the capital plan and the regulatory plan in one frame, which is the subtraction that is usually never performed.
THE INPUTS, AND WHAT THEY MEAN
- Next capital event
- A non-dilutive grant, a seed round, a Series A, a strategic partnership, or acquisition diligence. Each carries a different set of prerequisites because each counterparty is testing a different thing.
- Months until the event
- The months remaining until money must be committed. Counting to the first conversation rather than to the commitment is the most common way this map is set up wrong.
- State of each prerequisite
- Not started, in progress, or done. Done removes a prerequisite from the critical path; in progress is still counted at its full lead time, deliberately, because a partly-finished item is the one most often assumed to be nearly complete.
Does the regulatory work fit inside the runway?
Capital is planned against a date and regulatory work against a list, and the two are rarely subtracted from each other. Set the next capital event and how far away it is; SPEQ returns the latest date each prerequisite can start and flags the ones whose start date has already passed. The lead times are SPEQ planning estimates, not review clocks — replace them with your own.
A written, dated intended-use statement
Start by month 8 · 1 mo lead time
A controlled statement of use, user, setting and claim.
An evidence plan mapped to the claim
Start by month 7 · 2 mo lead time
A plan naming what will be shown, by what study, against which claim.
A regulatory strategy memo with its open questions named
Start by month 7 · 2 mo lead time
A written strategy, its assumptions, and what would change it.
A pre-submission or scientific-advice meeting requested
Start by month 3 · 6 mo lead time
A meeting request, briefing package and the authority’s written feedback.
A phase-appropriate quality system in operation
Start by month 3 · 6 mo lead time
Document control, change control, training and deviation handling actually in use.
A design and development record that reconstructs the decisions
Start by month 0 · 9 mo lead time
A traceable record from requirement through design to verification.
HOW TO READ THE OUTPUT
- The finding is the sign of the subtraction, not the size of the number. A prerequisite whose start date has passed does not delay the raise a little — it means the milestone the raise is timed on cannot be reached on the stated date without changing the plan.
- When several start dates have passed, the response is a different date, a smaller scope, or a different capital event. Starting all of them at once is the response that fails quietly.
- The critical path is the longest outstanding lead time, so shortening anything else changes nothing. This is the number to argue about with an investor, and the one to replace with your own estimate first.
- The lead times are SPEQ planning estimates and are labelled as such everywhere they appear. A founder who has a better number from their own advisers should use it.
WORKED EXAMPLE
A device company plans a Series A nine months out and has not yet requested a pre-submission meeting.
- Capital event
- Series A
- Months until the event
- 9
- Pre-submission meeting requested
- Not started
- Design and development record
- Not started
RESULT
The raise is timed on evidence of a defensible development record, and the estimate for building one is longer than the runway left. Nothing is wrong with either plan alone, which is exactly why this is found late — the two were never subtracted from each other.
REGULATORY BASIS
- ICH Q10
- Describes the pharmaceutical quality system as something operating across the lifecycle rather than assembled at filing, which is the basis for treating a quality system as a prerequisite with a lead time rather than an event.
- ICH Q9(R1)
- Establishes risk-based prioritisation of quality activities, which is what justifies sequencing prerequisites by consequence rather than by convenience.
- ISO 13485:2016
- Requires design and development planning with defined stages and records, which is why a design history is treated here as sustained work rather than a document produced on demand.