Best SOC 2 audit firms for biotech (2026)

Auditors ranked for biotech and life sciences companies whose audits routinely overlap with HIPAA, HITRUST, and 21 CFR Part 11 considerations.

How we picked: Auditors ranked for biotech and life sciences companies whose audits routinely overlap with HIPAA, HITRUST, and 21 CFR Part 11 considerations.

We filtered for AICPA-licensed firms with HIPAA in services offered AND healthcare or healthtech in industriesServed. Firms with HITRUST CSF Assessor accreditation ranked higher because biotech buyers selling into health systems frequently need both. We deprioritized firms whose primary industry focus is non-life-sciences (e.g., real estate, hospitality).

Schellman

Best for: Mid-market and enterprise biotech with HITRUST + SOC 2 needs

• HITRUST CSF Assessor accredited (Schellman profile).
• Lists healthtech in industriesServed (Schellman profile).
• Specialist firm focused exclusively on IT compliance (Schellman profile).

Pricing: Contact for pricing

A-LIGN

Best for: Biotech needing SOC 2, HIPAA, and HITRUST from a single multi-accredited firm

• Multi-accredited (HITRUST CSF Assessor, HIPAA capable) (A-LIGN profile).
• Lists healthtech and healthcare in industriesServed (A-LIGN profile).
• Fixed-fee available (A-LIGN profile).

Pricing: Contact for pricing

BARR Advisory

Best for: Mid-market biotech wanting a confirmed-pass boutique with HITRUST capability

• HITRUST CSF Assessor accredited (BARR Advisory profile).
• Confirmed AICPA peer review pass (BARR Advisory profile).
• Lists healthcare in industriesServed (BARR Advisory profile).

Pricing: Contact for pricing

KirkpatrickPrice

Best for: SMB biotech with HIPAA + SOC 2 needs and predictable timeline

• HITRUST CSF Assessor accredited (KirkpatrickPrice profile).
• Documented fieldwork timeline of 12 weeks (KirkpatrickPrice profile).
• Fixed-fee available (KirkpatrickPrice profile).

Pricing: Contact for pricing

Insight Assurance

Best for: Newer biotech startups wanting young boutique with HIPAA/HITRUST capability

• HITRUST CSF Assessor accredited (Insight Assurance profile).
• Lists healthtech in industriesServed (Insight Assurance profile).
• Documented fieldwork timeline of 8 weeks (Insight Assurance profile).

Pricing: Contact for pricing

Prescient Assurance

Best for: Startup-stage biotech wanting a boutique with HIPAA capability

• HITRUST CSF Assessor accredited (Prescient Assurance profile).
• Lists healthtech and fintech in industriesServed (Prescient Assurance profile).
• Fixed-fee available (Prescient Assurance profile).

Pricing: Contact for pricing

Also considered

Big Four firms have biotech-industry expertise but the entry price is generally not justified for a typical biotech SOC 2 unless consolidating with an existing Big Four financial-statement audit. Sensiba serves a broader client base (real estate, agribusiness, hospitality) — biotech buyers will get more specialist engagement teams elsewhere. Risk3sixty is SaaS-focused rather than life-sciences-focused.