Submission-specific structure
Start from the intended submission and expand the work into relevant modules, functions, deliverables, reviews, and decision points.
Submission Planner
Build the complete regulatory submission flow before execution begins.
Translate the submission strategy into structured workstreams, dependencies, milestones, owners, assumptions, and decision gates that the whole program can use.
Gulfstream Intelligence
Built for regulated work
- Structure IND, NDA, BLA, MAA, and other regulatory plans around the applicable program and submission objective.
- Connect regulatory, CMC, nonclinical, clinical, labeling, publishing, governance, and operational workstreams.
- Make dependencies and critical decisions visible instead of hiding them inside a spreadsheet or presentation.
- Use the plan in meetings, reports, gap follow-through, executive communications, and Slide Studio.
Human review
Private data
Traceable work
What it does
Purpose-built capability, connected to the rest of the program
Dependencies and sequencing
Show which activities can run in parallel, which require predecessor evidence, and which decisions control the critical path.
Milestones and assumptions
Anchor the plan to target dates while preserving the assumptions and constraints that make those dates credible.
Accountable ownership
Assign functional owners and clarify cross-functional handoffs before late-stage ambiguity becomes schedule risk.
CTD-aware working view
Relate execution activities to the expected regulatory content and document-readiness structure without reducing the plan to a file list.
One connected planning model
Reuse the same plan across working views and exported deliverables so dates, owners, and dependencies do not drift between tools.
Connected workflow
From source material to a usable regulatory output
- 01
Define the objective
Select the authority, submission type, target date, program stage, and known constraints.
- 02
Generate the working structure
Use Sailor and the planning model to build relevant workstreams, tasks, milestones, and assumptions.
- 03
Validate with functions
Confirm ownership, evidence readiness, dependencies, review cycles, and decision gates.
- 04
Operate from one plan
Use the plan in calendars, reporting, meetings, gap closure, and presentation outputs.
Designed for decisions
Keep the context that generic tools lose
Gulfstream connects source material, regulatory reasoning, planning, and deliverables so teams do not have to reconstruct the same work in disconnected systems.
- Replace disconnected spreadsheet dates with an explicit dependency model.
- Expose critical assumptions before teams commit to the target timeline.
- Clarify cross-functional ownership and handoffs.
- Connect submission content readiness to program execution.
- Keep executive reporting aligned with the working plan.
- Preserve one source of truth across exported planning views.
Questions regulatory teams ask
What is regulatory submission planning software?
It is software used to translate a regulatory submission objective into coordinated workstreams, deliverables, reviews, dependencies, milestones, owners, assumptions, and decision gates. It should connect the submission structure to the actual program work rather than functioning as a generic task list.
Which submission types can Gulfstream plan?
The planner is designed for life-science submissions and can support structures for INDs, NDAs, BLAs, MAAs, and other authority-specific objectives. Users configure the plan for the product, pathway, region, development stage, and applicable requirements.
Does the planner publish an eCTD submission?
No. Gulfstream Submission Planner organizes and coordinates the work that leads to a submission. Publishing and gateway transmission remain separate regulated operational activities using appropriately qualified systems and procedures.
Can Sailor generate a starting plan?
Yes. Sailor can help generate a structured starting flow from the stated submission objective and program context. Qualified functional owners should validate tasks, durations, dependencies, evidence assumptions, and authority-specific requirements before the plan is adopted.
How does it connect to gap assessment?
Confirmed readiness gaps can be converted into remediation tasks and dependencies so gap closure becomes part of the submission plan rather than a separate static report.
Can the plan be used in presentations and meetings?
Yes. The connected workflow allows the same milestones, decisions, risks, and assumptions to be used in meeting preparation, reporting, and Slide Studio without rebuilding the underlying story from scratch.
Continue exploring
Connected Gulfstream capabilities
Submission-plan template
Use the practical planning framework behind a defensible submission flow.
Learn moreRegulatory Gap Assessment
Identify the missing evidence and decisions the plan must resolve.
Learn moreSlide Studio
Translate the working plan into a decision-ready executive presentation.
Learn moreMove regulatory work forward