Biotech and life sciences

Biotech cybersecurity that protects your research and IP

Your value lives in research data, lab systems and intellectual property. We help biotech and life sciences companies protect it, meet partner and regulatory expectations, and build a security program that grows from first lab to commercial scale.

Talk to a biotech expert See compliance services
  • Protection for research data and intellectual property
  • Controls that support GxP and 21 CFR Part 11 work
  • A security program sized to your stage of growth
Lab researcher holding a sample plate
Two engineers reviewing log data at their workstations

The challenge

Why biotech is a target

Early-stage research, trial data and manufacturing processes are worth a great deal to competitors and nation-state actors. Biotech companies also tend to grow fast, with new hires, cloud apps, lab instruments and research partners added faster than security controls keep up.

The obligations stack up as you grow. Clinical and patient data can bring HIPAA and privacy laws such as GDPR into scope. Regulated GxP work brings FDA expectations for electronic records, and pharma partners and investors increasingly send security questionnaires or ask for SOC 2 or ISO 27001 before they sign.

  • Intellectual property and unpublished research data
  • Lab instruments and systems that are hard to patch
  • Collaborators and CROs with access to shared data
  • Rapid headcount growth and new cloud tools
  • Security reviews from partners, acquirers and investors

How we help

Biotech cybersecurity solutions for each stage

We start with what you need now and build a roadmap for the next stage, whether that is a first partnership, a clinical program or a commercial launch.

vCISO for growing biotech

Two CISOs per engagement who own your security roadmap, policies and partner questionnaires, and brief your board.

vCISO services

IP and research data protection

Identity and access controls, MFA and encryption that keep research data with the people who should have it.

Identity and access

SOC 2 and ISO 27001 readiness

Readiness work that answers partner and investor security reviews with an audited program.

SOC 2 readiness

Recurring penetration testing

A year-round testing schedule planned with you, so new systems and cloud apps are tested as you add them.

Continuous testing

24/7 managed detection and response

Around-the-clock monitoring of endpoints, cloud and identity, with analysts who investigate and contain threats.

Explore MDR

Cloud security

Configuration reviews and controls for research workloads in AWS, Microsoft Azure and Google Cloud.

Cloud security

Practical guide

Biotech cybersecurity compliance: five steps for startups

You don’t need a large security team to build a sound program. These five steps give a startup a foundation that holds up as it grows.

1. Map your data and the rules that apply

List the data you handle, where it lives and who can reach it. Patient or trial data may bring in HIPAA or GDPR. Records that support FDA submissions or GxP processes bring 21 CFR Part 11 expectations for trustworthy electronic records and signatures. Knowing which data triggers which rule keeps the program focused.

2. Protect data in layers

Encrypt data at rest and in transit, require multi-factor authentication for every account and limit access by role. For systems that hold regulated records, confirm they keep audit trails and restrict who can change or sign records.

3. Build a security-aware team

Researchers and operations staff are frequent phishing targets. Regular awareness training and phishing simulations help people spot attacks aimed at their accounts and your data.

4. Assess and test regularly

Use a framework such as NIST CSF or the CIS Controls to measure where you stand, and test your defenses with penetration testing. A recurring testing program keeps pace with new systems and cloud apps.

5. Plan for incidents and recovery

Write an incident response plan that covers detection, containment, recovery and notification, then rehearse it. Back up research data so a ransomware attack or failed system doesn’t cost you years of work.

Regulations and frameworks

Biotech cybersecurity compliance we help with

  • Security controls that support 21 CFR Part 11 electronic records
  • Access control and audit trail reviews for GxP systems
  • HIPAA safeguards for clinical and patient data
  • Privacy obligations such as GDPR for international data
  • SOC 2 and ISO 27001 readiness
  • NIST CSF and CIS Controls maturity assessments
  • Third-party risk reviews for CROs and research partners
  • Incident response planning and tabletop exercises

FAQ

Biotech cybersecurity questions

Earlier than most expect. Research data and IP have value from day one, and partners and investors often ask security questions during diligence. A light program with MFA, backups, monitoring and a few core policies is much easier to build early than to retrofit later.

System validation is usually owned by your quality team and software vendors. We support it with the security side: access controls, audit trail configuration, account reviews, backups and the policies that help show your electronic records are trustworthy.

GxP covers the good practice rules for regulated lab, clinical and manufacturing work. From a security view it means protecting data integrity, so records can’t be changed or deleted without a trace and only authorized people can create or sign them.

Yes. Our vCISO team answers questionnaires, fixes the gaps they reveal and builds toward SOC 2 or ISO 27001 so future reviews are faster.

The number of people, locations and systems in scope, whether you need ongoing monitoring, and which frameworks you are working toward. We scope the work after a short call and quote a fixed price.

Yes. We’re headquartered in San Diego, home to a large biotech community, and serve life sciences companies across the US.

Related services

Related services

vCISO services

Security leadership for companies without a full-time CISO.

vCISO

ISO 27001

An information security management system partners recognize.

ISO 27001

Healthcare

HIPAA risk analysis and protection for patient data.

Healthcare

Cybersecurity in San Diego

Security and compliance from our San Diego headquarters.

San Diego

Talk to a biotech expert

Protect your research as you grow

Tell us about your company, your data and your next milestone, and an advisor will reply by email to set up a conversation.

  • A security plan matched to your stage
  • Help with partner and investor security reviews

Prefer email? Write to [email protected] or call (858) 712-0040.

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