Due Diligence Checklists › Biotech › Pre-Seed
Biotech Startup Investment Checklist: Pre-Seed Stage (2026)
This checklist covers 24 due diligence items for Biotech startups at the Pre-Seed stage. Each item has been validated against institutional investor practice. DDR automates the majority of these checks from a single pitch deck PDF upload.
24 checklist items · 3 red flags automatically detected · See a sample DDR report
Pre-Seed Requirements
✓
Founding team quality and relevant domain expertise
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Problem evidence: clear pain, ideally lived experience
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Market size: TAM must justify a venture-scale outcome
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Early signal of demand: waitlist, LOIs, or first customers
✓
Founder-market fit: why this team for this problem
✓
Proprietary insight competitors don't have
Biotech Sector
✓
Core composition-of-matter patents verified and timeline confirmed
✓
Scientific advisory board reviewed with commitment letters
✓
In vivo efficacy data reviewed with expert scientific consultant
✓
FDA pre-IND meeting completed or scheduled
✓
CMC: manufacturing pathway documented for clinical quantities
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Freedom-to-operate legal opinion obtained
✓
Key scientist employment agreements with IP assignment confirmed
Deep Dive
✓
Scientific advisory board composition and engagement level
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Patent landscape: freedom-to-operate analysis and competitor IP
✓
Clinical trial design review with scientific expert
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Regulatory strategy: pre-IND meeting notes with FDA if available
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CMC (Chemistry, Manufacturing, and Controls) — manufacturing scalability
Regulatory
✓
Verify: FDA IND/NDA/BLA pathway: multiple review cycles, advisory committee meetings
✓
Verify: Clinical trial regulations: GCP compliance, IRB approval, informed consent
✓
Verify: Drug pricing scrutiny: IRA Medicare price negotiation for high-cost drugs
OSINT Signals
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Check: ClinicalTrials.gov: registered study status and enrollment progress
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Check: PubMed: peer-reviewed publications from founding team
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Check: USPTO patent database: core composition-of-matter patents
DDR AUTOMATES THIS CHECKLIST
Upload a Biotech startup pitch deck and DDR automatically completes 17+ of these 24 checklist items — sourcing data from 13 OSINT signals, benchmarking against 2 comparable companies, and detecting all 3 critical red flags.
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