At every stage, compromised systems can lead to questioned data and delayed outcomes.

What We Do

CyberGXP helps pharmaceutical organisations:

  • Protect clinical trial and patient data

  • Embed cyber controls into GxP environments

  • Maintain inspection-ready audit trails

  • Secure manufacturing, laboratory, and research systems

  • Govern CROs and third-party access

  • Demonstrate regulatory-grade cyber resilience

 All delivered in language regulators, auditors, and QA teams understand.

About Us
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Cyber Security as a Quality Function

CyberGXP aligns cyber security controls to quality and regulatory expectations, not IT trends.

Regulators assess cyber security through the lens of:

  • Data integrity (ALCOA+)

  • Audit trails and traceability

  • Access control and segregation of duties

  • Incident impact and recovery evidence

  • Third-party and CRO oversight

CRO & Third-Party Risk

Most regulatory data risk does not originate inside the sponsor organisation.

It originates through:

  • Contract Research Organisations (CROs)

  • Trial sites and laboratories

  • Cloud platforms

  • Temporary and external users

CyberGXP ensures:

  • Documented third-party cyber governance

  • Evidence-based oversight

  • Clear accountability

  • Demonstrable control during inspections

If your CRO compromises your data, regulators hold you accountable.

Regulatory Confidence Matters

Agencies such as the European Medicines Agency (EMA) assess not only clinical outcomes, but:

  • Whether data can be reconstructed

  • Whether access was controlled

  • Whether incidents were detected and managed

  • Whether integrity was maintained throughout the lifecycle

 

Weak cyber controls can delay or block approval — even when the science is sound.

Who We
Work With

  • Pharmaceutical manufacturers

  • Clinical-stage biotech companies

  • CRO-dependent trial organisations

  • Regulated life sciences manufacturers

 

From early development through commercial manufacturing.

A Simple Question

If a regulator asked tomorrow:
“Can you prove your clinical and manufacturing data has not been compromised?”
Would your answer be evidence-based — or hopeful?

Cyber Security designed for regulated pharmaceutical environments.

Because your approval depends on it.

Speak to a Specialist →