Healthcare Biotech · Pre-Seed Stage Due Diligence

Healthcare Biotech Pre-Seed Due Diligence Checklist

The complete Pre-Seed due diligence checklist for Healthcare Biotech startups. Prepare your data room, anticipate every investor request, and close your round faster.

All Checklists

1–2 weeks

Typical DD Timeline

5

DD Categories Covered

50+

Checklist Items Total

Healthcare Biotech Regulatory DD Context

Healthcare DD involves both regulatory and clinical review teams. HIPAA compliance, billing fraud risk, and FDA regulatory status are the three areas most likely to create deal delays.

Data Room Essentials for Pre-Seed

Documents to have ready before DD begins

  • Incorporation documents
  • Founder IP assignment agreements
  • Cap table (Carta or equity schedule)
  • Bank statements (3 months)
  • Any signed LOIs or customer contracts
  • Pitch deck and financial model

LEGALLegal Due Diligence

Basic corporate formation documents, founder IP assignment, and cap table verification. Investors rarely hire outside counsel at pre-seed — but they will verify these exist.

General Legal Items

  • Certificate of Incorporation and all amendments
  • Bylaws and any shareholder agreements
  • Cap table with fully diluted ownership by class
  • All convertible instruments (SAFEs, notes, warrants)
  • Option pool documentation and all grants
  • Founder IP assignment agreements
  • Co-founder agreements and vesting schedules
  • Material third-party agreements

Healthcare Biotech-Specific Legal Items

  • HIPAA Business Associate Agreements (BAAs) with customers
  • FDA 510(k) clearance, PMA approval, or exemption documentation
  • CMS reimbursement coding and coverage determination letters
  • State-level telemedicine and healthcare licensing
  • Physician self-referral (Stark Law) compliance review

FINANCIALFinancial Due Diligence

Bank statements for 3 months, any existing revenue documentation, and a basic projection model. Financial audit is not expected.

General Financial Items

  • Financial statements (P&L, balance sheet, cash flow)
  • Bank statements (12+ months)
  • Accounts receivable aging report
  • Accounts payable aging report
  • Payroll records and headcount history
  • Revenue recognition policy documentation
  • Tax returns and any outstanding tax obligations
  • Insurance policies (D&O, E&O, general liability)

Healthcare Biotech-Specific Financial Items

  • Revenue cycle management performance (AR days, collection rate)
  • Payer mix breakdown and reimbursement rate trends
  • Patient acquisition cost and lifetime value analysis
  • Prior authorization denial rate and appeal success
  • Contract rate renegotiation schedule with major payers

PRODUCTProduct and Technical Due Diligence

  • Clinical evidence publications and study designs
  • EHR integration status (Epic, Cerner, Oracle Health)
  • Cybersecurity framework for PHI protection
  • FDA post-market surveillance obligation status
  • Real-world evidence data collection methodology

MARKETMarket Due Diligence

  • Health system partnership pipeline and contract terms
  • Payer coverage policy review by major commercial insurers
  • ACO and value-based care contract participation
  • Clinical evidence comparison to standard of care

TEAMTeam Due Diligence

LinkedIn profile verification and informal reference calls with 2–3 professional contacts. Background check is increasingly common.

  • LinkedIn profiles for all founders and officers
  • Employment agreements for key personnel
  • Equity grant history and vesting schedules
  • Any prior employer IP invention disclosure forms
  • Non-compete and non-solicitation agreements
  • Professional reference contacts (3+ per founder)
  • Advisory board agreements and equity grants
  • Organizational chart as of current date

Frequently Asked Questions

How long does Pre-Seed due diligence typically take for Healthcare Biotech startups?

Healthcare Biotech Pre-Seed due diligence typically takes 1–2 weeks. Basic corporate formation documents, founder IP assignment, and cap table verification. Investors rarely hire outside counsel at pre-seed — but they will verify these exist. Having a complete data room ready before DD kicks off can reduce this timeline by 30–50%.

What Healthcare Biotech-specific items do investors review during Pre-Seed DD?

For Healthcare Biotech at the Pre-Seed stage, investors focus heavily on: HIPAA Business Associate Agreements (BAAs) with customers, FDA 510(k) clearance, PMA approval, or exemption documentation, and Revenue cycle management performance (AR days, collection rate), Payer mix breakdown and reimbursement rate trends. Healthcare DD involves both regulatory and clinical review teams. HIPAA compliance, billing fraud risk, and FDA regulatory status are the three areas most likely to create deal delays.

What should I put in my data room?

Your Pre-Seed data room should include: Incorporation documents; Founder IP assignment agreements; Cap table (Carta or equity schedule); Bank statements (3 months); Any signed LOIs or customer contracts; Pitch deck and financial model. Use a structured folder system that mirrors investor expectations — most institutional investors use a standard folder taxonomy.

What are the most common due diligence deal-killers?

The five most common DD deal-killers are: (1) undisclosed founder litigation or criminal history, (2) IP ownership gaps — particularly for university-origin technology, (3) customer contract terms that prevent assignment on change of control, (4) cap table math errors or undocumented equity grants, and (5) financial restatements required after revenue recognition review.

What team due diligence should I expect at the Pre-Seed stage?

LinkedIn profile verification and informal reference calls with 2–3 professional contacts. Background check is increasingly common.

Download the Full Checklist

Get the Healthcare Biotech Pre-Seed due diligence checklist as a Google Sheets or Notion template. Track completion status for every item in your data room.

Includes data room folder template, investor question tracker, and reference FAQ guide

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