Biotech

Penetration Testing for Biotech Companies

Biotech companies face attacks on research, clinical trial, and patient data worth billions. Breaches can harm competitive advantage, trigger FDA actions, and risk patient safety.

Book a Scoping Call

Penetration Testing for Biotech Companies

Biotech companies face attacks on research, clinical trial, and patient data worth billions. Breaches can harm competitive advantage, trigger FDA actions, and risk patient safety.

Book a Scoping Call

Industries/

Biotech

Why Biotech Companies Are Targeted

Research IP theft in biotech costs an estimated $600 billion annually. Nation-state actors and competitors target drug development data, clinical trial results, manufacturing processes, and patent applications.

Research IP Theft

Biotech IP theft costs over $600B annually, driven by nation-state and competitor attacks. A single breach can wipe out years of research advantage and billions in future revenue.

Clinical Trial Data Risks

Phase III results can move stock prices by billions within minutes. Attackers target trial databases for insider trading and competitive intelligence leverage.

Vulnerable Lab & Research Systems

Connected lab equipment and automated platforms often run outdated or insecure software. Breaches allow attackers to steal research data or disrupt experiments and production.

Collaboration & Regulatory Pressure

Universities, CROs, and manufacturing partners introduce weak security points. Strict rules like 21 CFR Part 11, HIPAA, GDPR, and SEC disclosure timelines increase risk exposure.

Common Vulnerabilities

Critical
Weak Access Controls
Insufficient permissions allow unauthorized users into research databases.
High
Unencrypted Data Transfer
Research data sent to partners without encryption risks interception. Attackers can capture IP during transit.
High
Default Credentials on Lab Equipment
Lab instruments still running default usernames and passwords. Easy entry point for attackers to access research systems.
Critical
Missing Audit Logging
Clinical trial systems lack activity logging and monitoring. Breaches go undetected and investigation becomes impossible.
Critical
Weak Authentication
Manufacturing and QA systems rely on weak or single-factor authentication.
Critical
Insecure File Sharing
Unprotected file sharing exposes confidential research and IP. Unauthorized users can copy or leak critical discoveries.

Common Vulnerabilities

Critical

Weak Access Controls

Insufficient permissions allow unauthorized users into research databases.

High

Unencrypted Data Transfer

Research data sent to partners without encryption risks interception. Attackers can capture IP during transit.

High

Default Credentials on Lab Equipment

Lab instruments still running default usernames and passwords. Easy entry point for attackers to access research systems.

Critical

Missing Audit Logging

Clinical trial systems lack activity logging and monitoring. Breaches go undetected and investigation becomes impossible.

Critical

Weak Authentication

Manufacturing and QA systems rely on weak or single-factor authentication.

Critical

Insecure File Sharing

Unprotected file sharing exposes confidential research and IP. Unauthorized users can copy or leak critical discoveries.

Compliance and Requirements for Biotech

Regulatory & Compliance Standards
GxP & Audit Trail Integrity
FDA Cybersecurity Inspection
Partner & Investor Security Expectations

Regulatory & Compliance Standards

FDA Cybersecurity Inspection

GxP & Audit Trail Integrity

Partner & Investor Security Expectations

What We Test in Biotech Environments

Our penetration tests are tailored to Biotech environments, covering the systems and workflows where breaches cause the most damage.

Clinical Trial Management Systems

Assessment of EDC platforms, trial management systems, and patient data databases for HIPAA and FDA compliance gaps. We test clinical trial platforms for authentication bypass, data manipulation vulnerabilities, and insufficient audit trails. We verify patient data is properly protected, trial results can't be altered, and systems meet FDA 21 CFR Part 11 requirements for electronic records.

Manufacturing & Quality Systems

Testing of biologics manufacturing systems, batch records, and quality management platforms for manipulation vulnerabilities. We test manufacturing execution systems, electronic batch records, and quality systems for unauthorized access and data integrity issues. We verify batch records can't be altered, manufacturing processes are protected from manipulation, and audit trails are complete.

IP & Patent Systems

Testing of patent application databases, regulatory submission systems, and IP management platforms for theft vulnerabilities. We test systems storing patent applications, regulatory submissions, and proprietary formulations. We verify IP is properly protected, access is restricted and monitored, and exfiltration attempts are detected.

Clinical Trial Management Systems
Assessment of EDC platforms, trial management systems, and patient data databases for HIPAA and FDA compliance gaps. We test clinical trial platforms for authentication bypass, data manipulation vulnerabilities, and insufficient audit trails. We verify patient data is properly protected, trial results can't be altered, and systems meet FDA 21 CFR Part 11 requirements for electronic records.
Manufacturing & Quality Systems
Testing of biologics manufacturing systems, batch records, and quality management platforms for manipulation vulnerabilities. We test manufacturing execution systems, electronic batch records, and quality systems for unauthorized access and data integrity issues. We verify batch records can't be altered, manufacturing processes are protected from manipulation, and audit trails are complete.
IP & Patent Systems
Testing of patent application databases, regulatory submission systems, and IP management platforms for theft vulnerabilities. We test systems storing patent applications, regulatory submissions, and proprietary formulations. We verify IP is properly protected, access is restricted and monitored, and exfiltration attempts are detected.
Manufacturing & Quality Systems
Assessment of EDC platforms, trial management systems, and patient data databases for HIPAA and FDA compliance gaps. We test clinical trial platforms for authentication bypass, data manipulation vulnerabilities, and insufficient audit trails. We verify patient data is properly protected, trial results can't be altered, and systems meet FDA 21 CFR Part 11 requirements for electronic records.

What You Get

Compliance-Ready Reports

Reports map to NIST CSF, CMMC, ISO 27001, and ITAR requirements. Formatted for auditors, insurers, and customer security assessments.

Compliance-Ready Reports

Reports map to NIST CSF, CMMC, ISO 27001, and ITAR requirements. Formatted for auditors, insurers, and customer security assessments.

Prioritized Remediation

Findings ranked by production impact with clear fix guidance for your IT and OT teams. Technical details included so teams can implement fixes without disrupting operations.

Free Retest Included

After implementing fixes, we retest at no cost to confirm vulnerabilities are resolved and provide updated documentation for compliance audits.

Ready to Test Your Environment?

Book a complimentary scoping call to discuss your systems, compliance requirements, and production schedule.

Get a Scoping Call

Ready to Test Your Environment?

Book a complimentary scoping call to discuss your systems, FDA requirements, and research protection needs.

Get a Scoping Call

4.8 out of 5