Sector

Pharma & Life Sciences

Assurance for R&D, manufacturing, clinical trials, and pharmaceutical supply chains — addressing regulatory expectations across MHRA, FDA, and EMA.

Threat Landscape

The pharmaceutical sector faces cyber threats targeting research and development, manufacturing systems, and supply chains. Nation-state actors target pharmaceutical organisations for access to proprietary drug formulations, clinical trial data, and vaccine research — as demonstrated during the COVID-19 pandemic. Ransomware operators target pharmaceutical companies recognising both financial return and healthcare supply chain disruption potential.

Manufacturing process compromise can affect drug safety and product integrity. The pharmaceutical supply chain — spanning contract manufacturers, ingredients suppliers, and distribution partners — creates broad exposure that extends well beyond the primary organisation.

Regulatory & Framework Landscape

IEC 62443 MHRA Expectations FDA Guidance EMA Guidance ISO/IEC 27001:2022 UK GDPR NIS2 Directive

Pharmaceutical organisations face regulatory expectations from the MHRA (UK), FDA (US), and EMA (EU) alongside general cybersecurity obligations. IEC 62443 applies to pharmaceutical manufacturing control systems. UK GDPR governs clinical trial participant data and employee information. NIS2 will expand cyber obligations for the healthcare supply chain.

CCM Domain Alignment

D14 OT/ICS Security 24 controls

Pharmaceutical organisations with manufacturing operations activate the D14 OT/ICS Security overlay alongside the mandatory baseline. This provides governance across enterprise IT (R&D systems, clinical trial data), manufacturing OT (process control, quality systems), and the converged integration points between them.

Operating Context

How C-PAP Supports Pharma & Life Sciences

C-PAP provides a unified assurance platform addressing R&D data protection, manufacturing security, and multi-jurisdictional regulatory compliance (MHRA, FDA, EMA) through a single governance framework. The platform consolidates intellectual property protection with safety-critical manufacturing controls.

For pharmaceutical organisations operating globally, C-PAP enables consistent governance across jurisdictions whilst accommodating the distinct regulatory expectations of each market through the CCM's multi-framework mapping capability.

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