Regulatory submission Gantt chart template with response window
An editable regulatory submission Gantt chart: gap analysis, parallel module authoring, internal review, publishing, submission and a window for answering questions, with dependencies and milestones.
What the regulatory submission gantt chart template with response window process is
A submission dossier is written by several people at once and then has to behave like a single document. The quality writer, the nonclinical writer and the clinical writer work independently, but the package can only be compiled when all of them are finished, reviewed and formatted the same way. The calendar slips at three places: when a gap in the source data is found late, when review comments arrive after formatting has started, and when the questions come back and nobody has time reserved to answer them. A timeline makes those places visible while there is still time to move them.
This template has four groups: Gap analysis and planning, Authoring modules, Review and publishing, and Submission and questions. It has 22 tasks, four of them milestones. "Define scope and content outline" (3 working days) is the only starting task. "Run gap analysis on available data" (6) and "Confirm authors and reviewers" (2) run side by side, and the "Gap analysis agreed" milestone waits for both. Nothing is written before it, because drafting against an unknown gap means writing twice.
Authoring is where the plan overlaps most. After the gap analysis, "Draft quality module" (15), "Close data gaps with missing reports" (8) and "Draft nonclinical summaries" (10) start together. "Draft clinical summaries" (14) starts 4 days after the missing reports start, so the writer begins on what exists while the rest arrives. "Write overview and cross-module summary" (6) follows the nonclinical summaries but is linked finish-to-finish with a 2-day lag to the clinical summaries, because an overview cannot finish before the text it summarises. "Prepare product information text" (5) starts 6 days into the clinical drafting.
The publishing gate is single on purpose. "Internal scientific review" (6) waits for the quality module, the overview and the product information text. "Address review comments" (5) follows, and "Format documents and navigation" (6) starts 3 days into it, so formatting begins on sections that are already settled. The "Content approved for publishing" milestone waits for both. Then "Compile and publish the package" (3), "Run technical checks on the package" (2) and "Submit to the authority" (1) run in a line, ending at "Submission sent".
After submission, "Authority review period" (30) is waiting time, not effort, and its length is an illustration: the real period and what happens in it are set by the authority and the procedure you are using, which this chart does not know. "Draft answers to questions" (8) and "Approve and send responses" (3) follow it and end at "Responses sent". Reserve the reply window by putting real people on those tasks, and compare the finish date with any deadline you are given. All durations are illustrative. A timeline schedules the work. It does not make a submission compliant, complete or approved, and it does not replace your regulatory advice. For the process side, see /templates/regulatory-filing-process, and for readiness work before an inspection see /templates/audit-preparation-gantt-chart. The same gate-and-sign-off logic runs through four neighbouring plans: /templates/clinical-trial-gantt-chart (a clinical study), /templates/medical-device-development-gantt-chart (device development), /templates/method-validation-gantt-chart (analytical method validation) and /templates/computer-system-validation-gantt-chart (computerised system validation).
What this flowchart covers
In this template
- Four groups, Gap analysis and planning, Authoring modules, Review and publishing and Submission and questions, with 22 tasks and four milestones: "Gap analysis agreed", "Content approved for publishing", "Submission sent" and "Responses sent".
- Parallel authoring: "Draft quality module", "Close data gaps with missing reports" and "Draft nonclinical summaries" start together, and "Draft clinical summaries" starts 4 days after the missing reports start.
- An overview tied to its sources: "Write overview and cross-module summary" follows "Draft nonclinical summaries" and finishes 2 days after "Draft clinical summaries" finishes.
- One publishing gate: "Content approved for publishing" waits for "Address review comments" and "Format documents and navigation", which starts 3 days into the comments.
- A reply window after submission: the 30-day "Authority review period" is followed by "Draft answers to questions" (8 days) and "Approve and send responses" (3 days).
When to use this template
- You are assembling a dossier from several authors and need to agree dates for each module and for the shared review.
- You want to see which late data gap or review comment would move the submission date.
- A sponsor or project lead asks when the package can be sent and you want to compare the finish date with the date you need.
- You want time for answering questions reserved in the plan before the submission is sent.
The plan, task by task
Every task in the chart with its length in working days and what it waits for. A dependency is a step number; SS is start-to-start, FF is finish-to-finish, and +n is a lag in working days.
| # | Task | Group | Working days | Depends on |
|---|---|---|---|---|
| 1 | Define scope and content outline | Gap analysis and planning | 3 | |
| 2 | Run gap analysis on available data | Gap analysis and planning | 6 | 1 |
| 3 | Confirm authors and reviewers | Gap analysis and planning | 2 | 1 |
| 4 | Gap analysis agreed | Gap analysis and planning | Milestone | 2, 3 |
| 5 | Draft quality module | Authoring modules | 15 | 4 |
| 6 | Close data gaps with missing reports | Authoring modules | 8 | 4 |
| 7 | Draft nonclinical summaries | Authoring modules | 10 | 4 |
| 8 | Draft clinical summaries | Authoring modules | 14 | 6SS+4 |
| 9 | Write overview and cross-module summary | Authoring modules | 6 | 7, 8FF+2 |
| 10 | Prepare product information text | Authoring modules | 5 | 8SS+6 |
| 11 | Internal scientific review | Review and publishing | 6 | 5, 9, 10 |
| 12 | Address review comments | Review and publishing | 5 | 11 |
| 13 | Format documents and navigation | Review and publishing | 6 | 12SS+3 |
| 14 | Content approved for publishing | Review and publishing | Milestone | 12, 13 |
| 15 | Compile and publish the package | Review and publishing | 3 | 14 |
| 16 | Run technical checks on the package | Review and publishing | 2 | 15 |
| 17 | Submit to the authority | Submission and questions | 1 | 16 |
| 18 | Submission sent | Submission and questions | Milestone | 17 |
| 19 | Authority review period | Submission and questions | 30 | 18 |
| 20 | Draft answers to questions | Submission and questions | 8 | 19 |
| 21 | Approve and send responses | Submission and questions | 3 | 20 |
| 22 | Responses sent | Submission and questions | Milestone | 21 |
How it works
Settle the gaps before writing
Keep "Run gap analysis on available data" and "Confirm authors and reviewers" ahead of "Gap analysis agreed". Replace the durations with how long your teams really need.
Start modules together, not all at once
Leave "Draft quality module", "Close data gaps with missing reports" and "Draft nonclinical summaries" parallel. Change the 4-day lag on "Draft clinical summaries" if reports arrive faster or slower.
Keep the overview behind its sources
The finish-to-finish link on "Write overview and cross-module summary" stops it ending before the clinical text. Add a module as a task that leads into it if your dossier has more.
Hold one publishing gate
Keep "Internal scientific review" before "Address review comments" and make "Content approved for publishing" wait for the formatting too. Add your own approvers as tasks if they need time.
Size the reply window deliberately
Set "Authority review period" from the procedure you are following, then put names and time on "Draft answers to questions" so the window is staffed before it opens.
Add owners, share and export
Put the responsible person in People, share the chart with authors and reviewers, and export a PDF or CSV when you need a copy for the project file.
Frequently asked questions
How long does a regulatory submission take to prepare?
It depends on the product, the amount of data and your procedure. The template uses illustrative working-day lengths. Replace them with your own and read the finish date from the chart.
Does the chart make a submission compliant or approved?
No. It schedules the work. The content, its quality and any decision by the authority are outside the chart, which only shows when each part is meant to happen.
Why is the review period a task?
Because it takes calendar time and the reply work waits for it. Its length here is an illustration, so replace it with the period your procedure sets and see how the dates move.
Can I add more modules or regions?
Yes. Add a drafting task per module in Authoring modules and make it lead into "Internal scientific review". For the filing process itself, see /templates/regulatory-filing-process, and for dependencies see /guides/gantt-chart-dependencies.
How do I show who writes which module?
Put the person in People on each task. See /guides/gantt-chart-with-owners for how owners are shown.