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Submission Builder

Build Every Section From The Evidence

Upload programme documents to one data room, draft and edit each section, and keep every claim connected through review and export.

Submission Types
Pre-INDINDNDABLAANDA…and others
TRIBAL BIO

Submission Builder

Milestone Document

Pre-IND Briefing Document

Draft Saved
1. Programme OverviewSources Attached

Development Programme Summary

TB-FLN-001 is an oral immediate-release capsule containing 5 mg flunarizine free-base equivalent. The programme is developing flunarizine for prophylaxis of paroxysmal attacks in alternating hemiplegia of childhood, initially in ATP1A3-confirmed patients aged 12 years or older who weigh at least 30 kg.

The development plan combines published nonclinical and clinical safety evidence with a new randomised, placebo-controlled Phase 2 study, and seeks Agency feedback on the regulatory pathway, CMC approach, nonclinical package and proposed study design.

Key Programme Facts
ProductTB-FLN-001 (flunarizine dihydrochloride)
Proposed IndicationProphylaxis of paroxysmal attacks in AHC
Current MilestoneType B Pre-IND meeting in Q1 2027

Choose a section to see the working draft update.

How It Works

From Source Files To Publishing

One connected workflow for authoring, review and handoff

  1. 01

    Author & Iterate

    Bring source files in, then draft and refine content with configurable AI support grounded in approved evidence.

  2. 02

    Assemble The Dossier

    Organise sections in the right structure while keeping tables, figures, citations and cross-references connected.

  3. 03

    Review Together

    Keep comments, redlines, reviews and approvals beside the content under discussion.

  4. 04

    Verify Sources

    Follow every claim to its source while preserving versions, decisions and approval history.

  5. 05

    Export Content

    Prepare controlled content for eCTD publishing, ready for your established publishing workflow.

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Frequently Asked Questions (FAQ)

About The Submission Builder

Which Documents And Submission Types Can We Build?

The workspace supports milestone documents across the development lifecycle, including Pre-IND briefing packages, INDs, NDAs, BLAs and ANDAs. Teams can also configure the structure for other regulatory dossiers and supporting documents.

How Does The Platform Preserve Traceability?

Draft claims remain linked to the evidence used to create them. Reviewers can move from a sentence to the relevant document and location, while versions, comments, decisions and approvals remain attached to the work.

Can It Produce An eCTD Submission?

The Submission Builder organises controlled content and exports it for an eCTD publishing workflow. Final compilation, technical validation and gateway submission remain part of your established publishing process.

Does Tribal Bio Submit Directly To Health Authorities?

The platform prepares the dossier and its supporting content. Sponsors retain control of final approval and submission to the relevant authority, either through their internal team or their publishing partner.

Can Our Own Experts And Consultants Work In The Platform?

Yes. Biotech teams, consultancies, CROs and CDMOs can bring their own reviewers into the workspace. Tribal Bio’s consultant network can also support strategy and review when additional expertise is needed.

See Your First Section Built From The Evidence

We will show you how the Submission Builder works with your programme and milestone

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