Your TMF Tells a Story About Your Trial.
Make Sure It's the Right One.

Comprehensive TMF review that identifies compliance gaps before they turn into findings.

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What We Deliver

Full TMF Audits

Comprehensive review of electronic TMF (eTMF) for completeness, quality, and regulatory compliance.

TMF QC / Gap Assessments

Targeted quality control reviews and gap analyses against your TMF Index, study-specific plans, and current regulatory expectations.

Pre-Inspection TMF Readiness

Mock BIMO/EMA inspections, readiness assessments, CAPA development, and remediation support prior to regulatory inspections.

eTMF System Support

Review of eTMF system configuration, migration, validation documentation, and processes to meet 21 CFR Part 11 / Annex 11 requirements.

Experience You Can Trust

Over 14 years in pharmaceutical Quality Assurance and Clinical QA, with extensive hands-on experience conducting TMF audits across numerous studies, CROs, and sponsors.

  • Deep experience auditing Veeva Vault and other modern eTMF platforms
  • Worked extensively with development-stage programs (Phase I–III) for small and mid-size biotech/pharma companies
  • Risk-based, practical auditing approach focused on regulatory priorities (ICH E6, FDA BIMO, EMA)
  • Independent audits — no conflicts with CROs, eTMF vendors, or sponsors
  • Clear, prioritized reports with realistic remediation guidance

Ready to Strengthen Your TMF?

Whether you're preparing for an upcoming inspection, remediating findings, or building routine TMF quality controls, we can help.