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Life-science due diligence checklist

Due diligence on a biotech, medtech or diagnostics company covers the usual corporate and financial areas plus the science, the intellectual property and the regulatory path. A practical checklist by area:

Area What reviewers look for
Science and data Study reports, raw-data ownership, data integrity, reproducibility
Intellectual property Patent families, status and expiry, ownership and assignment chain, inventors' assignments, licences in and out, freedom to operate
Clinical and regulatory Development phase, agency advice and commitments, designations, safety signals, path to approval
Manufacturing and quality CMOs, GMP status and audit findings, supply and technology-transfer rights
Contracts Licences, milestones and royalties, exclusivity, change of control, termination rights
Team Key people, invention-assignment and confidentiality clauses, option plans
Corporate and finance Cap table and share classes, board minutes, financial statements, runway, grants and their conditions

Deal-breakers first

Experienced investors check the few items that can stop a deal before everything else: ownership of the core IP, the regulatory status of the lead asset, and material contract restrictions. Haihtuva's round-1 screening starts from these.

AI due diligence · Preparing a data room