Source Document Upload
Bring Your Evidence Into One Place
Upload the reports, protocols and correspondence you already have. Tribal Bio organises the source material and extracts the facts your submission depends on.
AI Native Regulatory Services:
Pre-IND To NDA Submissions
Evidence-Based Strategy A Faster, More Confident Path Forward
Tribal Bio combines your programme’s evidence with relevant FDA precedents to develop a defensible regulatory strategy.
AI-assisted drafting and review by ex-FDA and large pharma consultants carry that strategy through to submission.
One Platform For The Whole Path From Source Evidence To Expert-Reviewed Submission
Your documents, strategy and writing in one connected workspace. AI moves the work forward. Regulatory experts stay in the loop.
Gap Analysis
See What’s Missing Before You Start Writing
Check the evidence base for missing documents, unresolved questions and conflicting data. Give your team a clear view of what needs attention.
AI-powered Strategy
Build A Strategy With The Evidence Behind It
Connect your programme data with FDA guidance, prior approvals and regulatory precedents. Compare pathways and study designs with the rationale and trade-offs in view.
AI Co-Authoring
Turn Source Evidence Into A Working Submission
Draft your Pre-IND briefing document in the same workspace as your team. Every claim stays connected to its source, and every revision keeps the reasoning intact.
- Draft complete sections, tables and milestone-specific content.
- Select your sources and regenerate the affected sections.
- Collaborate through comments, redlines and approvals.
Agentic Quality Control
Catch Inconsistencies Before Expert Review
AI agents check completeness, source support and consistency across sections. Missing evidence and conflicting values surface as clear findings for your team to resolve.
Consultant Review
Expert Judgement At The Moments That Matter
Review with Tribal Bio’s consultant network, or bring your own experts into the platform. Consulting agencies, CROs and CDMOs can use the same workspace with their own teams to review strategy, resolve feedback and approve the submission.
20+
consultants across regulatory strategy, CMC and quality
Our consultants bring experience from
Current and previous roles across our consultant network
Built For Scrutiny Every Recommendation Can Be Traced To A Precedent
FDA Precedent
Recommendations are grounded in what the FDA has actually accepted: approved labels, review documents and prior submissions for similar programmes. You see the precedent behind each suggested path, not just the answer.
Evidence First
Every statement in a draft links to its source document, table and page. Reviewers can see how each conclusion was reached, and nothing enters a section without a source.
Experts In The Loop
Regulatory, CMC and clinical specialists review the work before it leaves the platform. AI does the drafting; people make the calls.
Benchmarks
Package cost and preparation time, compared with a traditional consultancy
80%
Lower IND Package Cost
$30kTraditional Baseline: $150k67%
Shorter Preparation Time
4 weeksTraditional Baseline: 12 weeksThe Team
We Know The Work Behind The Submission
We are a team of regulatory consultants, clinicians, engineers with experience across drug development and clinical research.
Meet The TeamUse Cases
For Lean Development Teams
Take Your Programme From Evidence To Submission
Bring source documents, strategy, drafting and expert review into one connected regulatory workspace.
For Regulatory Advisors
Deliver Evidence-Linked Client Submissions
Draft, review and approve work with every source, decision and revision kept in one place.
For Development Partners
Collaborate With Sponsors In One Workspace
Move from source evidence through feedback and approval without losing context between teams.