Biotech Startup Due Diligence Checklist for Investors (2026)
This checklist covers 18 due diligence items for Biotech startups. Each item has been validated against institutional investor practice. DDR automates the majority of these checks from a single pitch deck PDF upload.
18 checklist items · 3 red flags automatically detected · See a sample DDR report
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
✓
Freedom-to-operate legal opinion obtained
✓
Key scientist employment agreements with IP assignment confirmed
Deep Dive
✓
Scientific advisory board composition and engagement level
✓
Patent landscape: freedom-to-operate analysis and competitor IP
✓
Clinical trial design review with scientific expert
✓
Regulatory strategy: pre-IND meeting notes with FDA if available
✓
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
✓
Check: ClinicalTrials.gov: registered study status and enrollment progress
✓
Check: PubMed: peer-reviewed publications from founding team
✓
Check: USPTO patent database: core composition-of-matter patents
DDR AUTOMATES THIS CHECKLIST
Upload a Biotech startup pitch deck and DDR automatically completes 13+ of these 18 checklist items — sourcing data from 13 OSINT signals, benchmarking against 2 comparable companies, and detecting all 3 critical red flags.
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