Biotech Cybersecurity
Cybersecurity Services for U.S. Biotech, Pharmaceutical R&D, and Medical Device Companies
BlueRadius Cyber provides biotech-specialized cybersecurity services to U.S. drug discovery firms, clinical-stage biotech companies, contract research organizations, contract manufacturing organizations, gene and cell therapy firms, medical device manufacturers, and pharmaceutical R&D operations. We build programs that protect intellectual property of extraordinary state-sponsored interest, satisfy FDA cybersecurity guidance for connected medical devices, handle HIPAA exposure for clinical data, support GxP-aligned change control, and provide the fractional CISO leadership investor due diligence demands.
Why Biotech Cybersecurity Is a Different Discipline
Biotech security shares HIPAA exposure with general healthcare (see our healthcare cybersecurity hub for that broader vertical), but adds three concerns generic enterprise security firms typically miss: intellectual property protection against state-sponsored actors, FDA cybersecurity for connected medical devices, and GxP-aligned change management for systems supporting clinical trials and manufacturing.
The IP dimension is the most underrated. Drug formulations, clinical trial datasets, manufacturing processes, and platform technology have valuation in the billions of dollars for late-stage assets. State-sponsored attackers, particularly from China and Russia, actively target biotech firms for these assets. The attack pattern typically begins with spear phishing of research scientists, escalates through credential compromise into the research environment, and concludes with data exfiltration that may not be discovered for months or years.
What We Cover
IP Protection Against State-Sponsored Threats
Identity-first detection (most IP-theft attacks start with credential compromise), strong network segmentation between corporate IT and research environments, data loss prevention focused on research output, secure remote access for collaborator scientists, and incident response that accounts for IP exposure as a distinct consequence dimension.
FDA Cybersecurity for Connected Medical Devices
Secure-development programs, threat models, premarket cybersecurity packages, software bills of materials (SBOMs), and post-market security update strategies aligned to FDA's 2023 cybersecurity guidance for connected medical devices and combination products.
GxP-Aligned Security Programs
Security controls supporting GMP, GCP, and GLP environments require change-control discipline that generic IT security frameworks don't enforce. We build security programs that satisfy GxP audit expectations alongside ISO 27001 or SOC 2 frameworks the company may also pursue.
HIPAA for Clinical Data
Clinical-stage biotech handles patient data that triggers HIPAA Security Rule obligations even when the company is not itself a healthcare provider. We build HIPAA programs aligned to the clinical workflow and partner-handling realities biotech faces.
CRO and CMO Vendor Risk Management
Biotech increasingly depends on contract research and manufacturing organizations. A CRO compromise can expose the sponsor's IP and clinical data. We build vendor risk programs covering CRO and CMO security review, contractual security requirements, and ongoing monitoring.
Virtual CISO for Investor Due Diligence
Series B and later biotech investors increasingly expect a named CISO and documented security program during financing rounds. Our vCISO consultants serve as the named CISO investors expect, with program documentation, board reporting, and the policy materials needed to satisfy reviews.
Compliance Programs
SOC 2 Type II (for digital health and biotech IT vendors selling into health systems), HIPAA Security Rule (for clinical data handling), FDA cybersecurity (for connected medical devices), and ISO 27001 (often required for international clinical trials). See our regulatory compliance practice and SOC 2 compliance services hub.
24/7 Managed Detection and Response
SOC monitoring tuned for biotech threat patterns: spear phishing campaigns targeting research scientists, lateral movement into research environments, credential abuse, OAuth grant abuse against research SaaS tools. See our managed cybersecurity services hub.
Who We Serve
- Drug discovery firms and clinical-stage biotech
- Gene therapy and cell therapy companies
- Contract research organizations (CROs)
- Contract manufacturing organizations (CMOs)
- Medical device manufacturers (connected devices, in-vitro diagnostics, combination products)
- Pharmaceutical R&D operations
- Digital health platforms with biotech adjacency
- Biotech-focused academic medical centers and research institutions
Biotech-Heavy Local Practices
Our local practices in the major U.S. biotech metros carry deep biotech specialization:
Frequently Asked Questions
What does biotech cybersecurity services include?
Biotech cybersecurity programs typically cover intellectual property protection (drug formulations, clinical trial data, manufacturing processes), HIPAA compliance for patient data handling, FDA cybersecurity for connected medical devices, GxP-aligned change control, secure laboratory environments, contract research organization (CRO) vendor risk, and incident response designed for environments where research disruption has financial and regulatory consequences. Most engagements include fractional CISO leadership to satisfy investor due diligence and board reporting.
How is biotech cybersecurity different from general healthcare security?
Biotech security shares HIPAA exposure with general healthcare but adds three distinct concerns: intellectual property protection (clinical trial data and drug formulations are state-sponsored targets), FDA cybersecurity for connected medical devices and combination products, and GxP-aligned change management for systems supporting clinical trials and manufacturing. Hospital-focused security programs underweight all three. Generic enterprise security firms often miss the GxP and FDA dimensions entirely.
Do you handle FDA cybersecurity for connected medical devices?
Yes. The FDA's 2023 cybersecurity guidance for connected medical devices requires premarket submissions to include cybersecurity documentation: threat models, software bills of materials (SBOMs), secure-development evidence, and post-market security update strategies. We build the cybersecurity packages medical device companies need for premarket submissions and the post-market programs FDA examiners look for during inspections.
What does biotech cybersecurity typically cost?
Mid-market biotech engagements typically run $8,000 to $25,000 per month for an integrated managed security and fractional CISO program. Biotech firms with substantial clinical trial activity, FDA-regulated medical device development, or significant IP protection requirements typically run $20,000 to $40,000 per month. Final pricing scales with R&D footprint, clinical trial scope, FDA-regulated activities, and incident response coverage.
How do you protect biotech IP against state-sponsored attackers?
Biotech IP protection requires layered controls: identity-first detection (state actors often start with credential compromise via spear phishing), strong network segmentation between corporate IT and research environments, data loss prevention focused on research output, vendor risk programs covering CROs and manufacturing partners, and incident response runbooks that account for IP exposure as a separate consequence dimension from regulatory exposure. Generic enterprise security underweights the IP dimension.
Who do you serve in biotech?
Drug discovery firms, biotech startups, contract research organizations (CROs), contract manufacturing organizations (CMOs), clinical-stage biotech companies, gene therapy and cell therapy firms, medical device manufacturers, digital health platforms with biotech adjacency, and pharmaceutical R&D operations. Our local practices in Boston, the Bay Area, and San Diego carry deep biotech specialization.
Start with an Assessment
The fastest way to know whether your biotech cybersecurity program matches your IP, HIPAA, and FDA risk profile is a structured assessment. We map your current controls across research, clinical, manufacturing, and corporate environments, identify the work required, and return a written gap analysis with a realistic timeline and budget. Request a free cybersecurity assessment.