# Biotech VC Due Diligence Checklist for a Series A: What to Verify Before You Wire > A rigorous Series A biotech due diligence process covers seven domains: science and IP, regulatory pathway, clinical data, team, financials, competitive landscape, and red flags. This explainer gives healthcare investors a specific, source-by-source checklist and tells you exactly where to look. ## What Does a Complete Biotech Series A Due Diligence Checklist Cover? A complete Series A biotech due diligence checklist covers seven domains in a specific order: (1) scientific foundation and mechanism of action, (2) intellectual property position, (3) regulatory strategy and pathway clarity, (4) existing preclinical or early clinical data, (5) team credentials and track record, (6) financial model and use of proceeds, and (7) competitive and exit landscape. Skipping any domain or checking them out of order is the single most common mistake early-stage healthcare investors make. The sections below give you the exact primary sources to verify each domain yourself. ## How Do You Validate the Science Before Trusting the Pitch Deck? Start with PubMed (pubmed.ncbi.nlm.nih.gov) and search the lead scientist's name plus the mechanism of action. Count peer-reviewed publications in the last five years, note whether the company's own data have been independently replicated, and read the Methods sections yourself or hire a scientific consultant who will. Look for animal model relevance to humans: rodent data that does not translate is the most common scientific red flag in early biotech. Check ClinicalTrials.gov for any registered studies, even exploratory ones, and read the study design, endpoints, and estimated completion dates directly. A company that has registered a trial but has not started enrollment after 18 months deserves a pointed question. ## Where Do You Check the IP Position, and What Specifically Are You Looking For? Go to the USPTO Patent Full-Text and Image Database (patents.google.com mirrors it cleanly) and search the assignee name and the lead inventor names separately. For each patent family, confirm: filing date, priority date, expected expiration, claim breadth, and whether the claims cover the specific formulation and indication the company is pursuing, not just a broad genus. Then cross-reference with espacenet.com for international filings. The critical mistake here is accepting an IP summary memo from company counsel without verifying the claims yourself. Also pull any inter partes review (IPR) petitions on the USPTO PTAB portal to see if any of the core patents are under challenge. Finally, confirm in the term sheet that IP is assigned to the company, not licensed from a university under terms that allow the university to sublicense to a competitor. ## How Do You Assess Regulatory Pathway Risk at the Series A Stage? Look up the relevant FDA guidance documents on fda.gov under the Guidance Documents database. Search the target indication and read the most recent draft and final guidances to understand what endpoints FDA expects in pivotal trials. Then request the company's IND application summary or pre-IND meeting minutes. A company that has held a pre-IND meeting and has written FDA feedback is meaningfully de-risked compared to one operating purely on internal assumptions. Check the FDA Orphan Drug Designations database if the company claims orphan status; the designation is public and verifiable in minutes. Breakthrough Therapy and Fast Track designations are also publicly listed on FDA.gov and should be confirmed rather than taken on the company's word. ## What Financial and Operational Metrics Matter Most at Series A? For private companies, you will rely on audited financials provided in the data room, but verify the auditor: a Big Four or nationally recognized specialty healthcare auditor is a meaningful signal. Model the cash runway yourself using the company's stated monthly burn rate and the proposed use of proceeds, then stress-test it by assuming a 30 percent cost overrun and a six-month clinical delay. Both are historically common. For any company that has received SBIR or STTR grants, verify award amounts on usaspending.gov; misrepresentation of grant funding is a documented fraud pattern. Pull SEC EDGAR (sec.gov/cgi-bin/browse-edgar) to check if any principals or affiliated entities have prior securities filings or enforcement actions. ## How Do You Background-Check the Management Team Efficiently? Verify every credential listed on LinkedIn against primary sources. Medical degrees and board certifications are verifiable through the American Medical Association's DoctorFinder or state medical board websites. PhD credentials can be confirmed through the granting institution's alumni directory. Prior biotech exits should appear in SEC EDGAR M&A filings or press releases with verifiable dates and deal values. Check PACER (pacer.gov) for any federal litigation history involving the CEO or CSO. Reference calls matter: speak to at least two former direct reports, not only the references provided by the company. ## What Does the Competitive and Exit Landscape Analysis Require? Map every asset in the same indication and mechanism class using ClinicalTrials.gov's advanced search filtered by condition and intervention type. Build a simple grid showing phase, sponsor, primary endpoint, and estimated readout date. Then check recent M&A and licensing comps: SEC EDGAR 8-K filings from large pharma disclose deal terms and often include milestone structures that let you reverse-engineer valuation multiples. Evaluate whether the company's differentiation claim, usually better safety, superior efficacy, or a novel biomarker, is supported by published head-to-head data or is purely theoretical. ## Series A Biotech Due Diligence Checklist: Quick Reference - Science: PubMed citations verified, independent replication confirmed, animal model relevance assessed - IP: USPTO patent claims read directly, PTAB IPR challenges checked, university license terms reviewed - Regulatory: FDA guidance documents read, pre-IND or IND meeting minutes reviewed, designations verified on FDA.gov - Clinical data: ClinicalTrials.gov registration confirmed, enrollment status checked, endpoints mapped to FDA guidance - Team: Degrees confirmed via primary sources, PACER litigation check completed, two non-company references contacted - Financials: Audited statements reviewed, burn and runway stress-tested, SBIR grants verified on usaspending.gov, SEC EDGAR principal search completed - Competitive landscape: ClinicalTrials.gov competitor grid built, M&A comps pulled from 8-K filings ## How Can You Accelerate This Process Without Cutting Corners? MedFuel Intel automates the primary-source verification steps above using AI-powered due diligence reports that pull live data from FDA databases, ClinicalTrials.gov, USPTO, SEC EDGAR, and PubMed into a single structured report with red flag scoring. Instead of spending 40 to 60 hours per deal on database pulls, analysts get a verified foundation in hours and spend their time on the judgment calls that actually require human expertise. Run a free Red Flag Screener on your current pipeline at https://medfuelintel.com and see which deals have verifiable issues before you go deeper. --- Informational only, not investment advice. --- Source: MedFuel Intel (https://www.medfuelintel.com/geo/article/biotech-vc-due-diligence-checklist-for-a-series-a). Grounded in primary-source-verified events; verify against SEC, FDA, and ClinicalTrials.gov before any investment decision.