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Managed Detection & Response, 24/7 AI-agentic detection & response Co-Managed SOC, Your team and ours, one operation Detection Engineering, Coverage you can measure Incident Response Retainer, A hand on the wheel before you need it Penetration Testing, See your estate the way attackers do Red & Purple Teaming, Offence that hardens your defence Continuous Security Validation, Validate continuously, not annually Cyber Crisis Tabletop & War-Gaming, Rehearse the bad day Continuous Threat Exposure Management, From a list of vulns to a plan Cyber Risk Quantification, Risk as a number the board can use Managed Threat Intelligence, Signal, not noise Digital Risk & Brand Protection, Protect your name where you cannot see Managed OT & IoT Monitoring, Security for systems that cannot go down OT/ICS Assessment, Know your OT before an attacker does Compliance as a Service, Gap assessment to certification Third-Party & Supply-Chain Risk Management, Risk does not stop at your perimeter Virtual CISO & Governance Advisory, Executive security leadership, on tap AI Security & Governance, Govern the AI you are adopting Managed Content Custody, Custody for your crown jewels

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Maritime, Fleets, ports and shore-side IT Media & Entertainment, Pre-release content and production Casino & Gaming, Platform integrity and player trust Financial Services, DORA, resilience and fraud Critical National Infrastructure, Converged IT and OT estates Manufacturing, Plants, PLCs and supply chain Healthcare, Clinical systems and patient data Pharmaceutical & Life Sciences, Research IP, GxP and data integrity Energy & Utilities, Generation, grid and SCADA Government, Sovereign data and assurance

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Home / Industries / Pharmaceutical & Life Sciences
Industry

Decades of R&D, one exfiltration away

Pharma and life sciences run on two things attackers want: irreplaceable research IP, and tightly regulated, validated systems that cannot simply be patched or taken offline. HexaShield protects formulations, trial data and GxP manufacturing in one monitored, evidenced estate — passively, and without breaking validation or data integrity.

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Integrity-first
GxP data you can defend
A falsified record is a regulatory event, not just a security one.
Where we are brought in

Four problems we are asked to solve in pharma & life sciences

The value here is invented, not held on a balance sheet, and the systems that make and prove the product are regulated to the last record. These are the situations research organisations, manufacturers and biotechs bring to us most often, and what we put against each.

01

Your research IP is the product, and it is the target

INT
The problem

A pharma or biotech company’s value is decades of R&D: formulations, assay data, trial results and regulatory dossiers. These are hunted by nation-state espionage and ransomware crews who know a single exfiltration, or a leaked trial, can erase an advantage that cost billions.

How HexaShield solves it

HexaInt watches criminal forums and the dark web for leaked credentials, stolen dossiers and pre-announcement trial data; HexaSOC detects intrusion and exfiltration early; and HexaCustody holds your crown-jewel research and submissions in tamper-evident custody.

Cyber Intelligence + SOCHexaIntHexaSOCHexaCustody
The business outcome

The IP that is your business is watched the way a vault is watched — a leak is caught while it is still a login, not after it is a headline.

02

GxP manufacturing cannot go down, and cannot be freely patched

OT
The problem

Bioreactors, fill-finish lines, cleanroom HVAC and the SCADA and MES behind them are validated systems. A batch cannot be interrupted, most devices cannot take an agent, and patching often means costly revalidation — so security is quietly deferred.

How HexaShield solves it

HexaOT discovers and monitors the GxP and facilities estate passively, safe for continuously validated operation, and feeds the same SOC as your corporate IT so one team sees an incident that crosses both worlds.

Operational TechnologyHexaOT
The business outcome

A complete, current view of the OT running production — without a scan that could put a validated system into a state it was never qualified for.

03

Data integrity must satisfy an inspector, continuously

GRC
The problem

21 CFR Part 11, EU GMP Annex 11, GAMP 5 and ALCOA+ demand not just that controls exist, but that they demonstrably operate. A data-integrity failure is a regulatory catastrophe — warning letters, consent decrees, even import bans.

How HexaShield solves it

HexaComply, delivered as Compliance as a Service, maps one control set across Part 11, Annex 11 and your quality system, keeps audit-ready evidence live, and takes you from gap assessment through to inspection.

Governance, Risk & ComplianceHexaComply
The business outcome

Inspection-ready evidence produced by operating — not assembled in a panic before an FDA or MHRA visit — and data integrity you can prove.

04

The research and supply ecosystem is vast and porous

GRC
The problem

CROs, CDMOs, contract labs, cold-chain logistics and serialisation partners all touch your data and your product. Their exposure becomes yours, and one compromised partner can halt supply or leak a trial.

How HexaShield solves it

HexaComply runs continuous third-party risk across your CRO, CDMO and supplier base, enriched by HexaInt’s external exposure signal, so a partner’s weakness is visible before it becomes your incident or your recall.

Governance, Risk & ComplianceHexaComplyHexaInt
The business outcome

Supplier and CRO risk scored and monitored continuously, so the weakest link in a global supply chain is known before it breaks.

What sits behind it

The problems, and what answers each

Each situation, the capability that answers it and the platform it is delivered on
#The situationCapabilityDelivered on
01Your research IP is the product, and it is the targetCyber Intelligence & SOCHexaInt
02GxP manufacturing cannot go down, and cannot be freely patchedOperational TechnologyHexaOT
03Data integrity must satisfy an inspector, continuouslyGovernance, Risk & ComplianceHexaComply
04The research and supply ecosystem is vast and porousGovernance, Risk & ComplianceHexaComply

The frameworks your assurance has to answer to

FDA 21 CFR Part 11 for electronic records and signatures · EU GMP Annex 11 for computerised systems · GxP (GMP/GLP/GCP) and GAMP 5 for validation · data integrity expectations (ALCOA+) from the FDA and MHRA · NIS2 where pharmaceutical manufacturing is an important entity · DSCSA and the EU Falsified Medicines Directive for serialisation and track-and-trace.

We map the ones that apply to your jurisdiction, product and market during onboarding rather than assuming them here. Compliance frameworks and regulatory requirements change over time; the specific frameworks in scope, and their current requirements, are confirmed and verified with your counsel during onboarding.

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Scoped around validated systems and data integrity, not a generic IT checklist.

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Threat landscape

What actually goes wrong in pharma & life sciences

Industrial espionage & IP theft

Well-resourced nation-state and competitor actors target formulations, assay data and trial results — patiently, and for years.

Ransomware halting production

Encryption of MES, LIMS or release systems can stop manufacturing and delay medicines patients depend on.

Data-integrity attacks

Altering or fabricating GxP records is both a patient-safety risk and a regulatory catastrophe.

Legacy validated systems

Equipment that cannot be patched without revalidation runs for years on unsupported software.

CRO, CDMO & supplier compromise

Partners across research, manufacturing and logistics hold sensitive data and deep connectivity into your estate.

Counterfeiting & supply diversion

Gaps in serialisation and the cold chain enable falsified medicines and product diversion.

One connected picture

Lab, plant and clinical systems, in one place

Research instruments, validated manufacturing OT and clinical-trial systems rarely appear in the same inventory, let alone the same monitored estate. HexaCore brings them together, passively, so the whole life-sciences estate is seen, correlated and evidenced as one.

Lab & R&D systems ELN, instruments, assay data
GxP manufacturing OT Bioreactors, fill-finish, SCADA/MES
Quality & LIMS LIMS, MES, QMS, batch records
Clinical trial data GCP systems, eTMF, CRO links
Corporate IT & identity Mail, SSO, endpoints
CRO/CDMO & supplier access Partner and vendor connectivity
HexaCore Resilience core Correlate · enrich · decide
Every validated system visible Including the ones never inventoried
Part 11 & Annex 11 evidence Produced by operating, not by project
IP & trial data protected Watched like the asset it is

Discovery is passive because a qualification scan can put a validated system into a state it was never tested in. On a GxP network, the security tool must never be the thing that triggers a deviation.

Obligations

The regulatory picture

The frameworks and regimes that shape security and quality programmes in this sector. HexaComply maps one control set across all of them.

FDA 21 CFR Part 11

Electronic records and electronic signatures for FDA-regulated records in the US.

EU GMP Annex 11

Requirements for computerised systems used in GMP-regulated activities.

GAMP 5

A risk-based approach to computerised system validation (CSV / CSA).

Data integrity · ALCOA+

FDA and MHRA expectations that data is Attributable, Legible, Contemporaneous, Original and Accurate.

NIS2

Manufacture of pharmaceuticals is in scope as an important entity in the EU.

DSCSA & EU FMD

Serialisation and track-and-trace to keep falsified medicines out of the supply chain.

The approach

How HexaShield covers it

  1. 1See validated OT & lab systems, passively

    HexaOT discovers GxP and laboratory technology without a scan that could risk revalidation.

  2. 2Detection that respects validated state

    Investigation is automated and containment is guard-railed, so a response never breaches GxP or spoils a batch.

  3. 3Protect IP, formulations & dossiers

    HexaCustody holds crown-jewel research and submissions in tamper-evident custody; HexaInt watches for leakage.

  4. 4Supplier & CRO exposure monitored continuously

    HexaComply and HexaInt track third-party risk across the whole research and supply ecosystem.

  5. 5Part 11, Annex 11 & data-integrity evidence by operating

    HexaComply maps one control set across the regimes and keeps evidence inspection-ready every day.

The platform

Modules that do the work

HexaOT

OT & ICS security

Explore HexaOT

HexaSOC

AI agentic SOC & MDR

Explore HexaSOC

HexaInt

Cyber & dark-web intelligence

Explore HexaInt

HexaCustody

Digital content custody

Explore HexaCustody

HexaComply

Compliance & TPRM

Explore HexaComply

HexaCore

The unified resilience core

Explore HexaCore

One accountable partner

Integrated capabilities and proprietary platforms under one operating model, so there is no gap between the team that detects something and the team that answers for it to a regulator.

No rip-and-replace

We sit above the stack you already run and take telemetry from any source. Nothing here depends on you re-validating systems or replacing tooling you have already qualified.

Transparency by default

Whatever you buy feeds HexaView, the same truth our analysts see, at the depth each audience needs, exported on demand for leadership, auditors and inspectors.

FAQ

Questions, answered

How do you secure validated GxP systems without triggering revalidation?
By monitoring the network, never the device. HexaOT identifies GxP and laboratory technology, its firmware and its communication patterns from observed traffic, so validated systems that can never take an agent are still inventoried and monitored — with no probing traffic that could put them into an unqualified state.
Will this affect 21 CFR Part 11 compliance or data integrity?
No. Monitoring is passive and read-only; it generates evidence rather than altering records. Response actions in GxP environments are guard-railed and approval-gated, so containment decisions are made with batch integrity and validation in view.
Can you protect research IP and clinical-trial data specifically?
Yes. HexaCustody holds crown-jewel research, formulations and regulatory submissions in tamper-evident custody; HexaInt watches criminal forums and the dark web for leaked credentials and stolen data; and HexaSOC detects intrusion and exfiltration across your estate.
Do you help prepare for FDA, EMA or MHRA inspection?
Yes. HexaComply maps one control set across 21 CFR Part 11, Annex 11, GAMP 5 and your quality system, and keeps the supporting evidence live, so inspection readiness is a state you are in continuously rather than a project you scramble to complete.
Other sectors

We work across resilience-critical industries

HealthcareMedical device and clinical system visibility that never interrupts care, evidenced for HIPAA and the DSPT. ManufacturingPlant visibility without downtime, plus IEC 62443, CMMC 2.0 and TISAX evidence for your customers. Financial ServicesDORA and NIS2 evidence, ICT third-party risk and resilience testing that runs continuously. Critical National InfrastructureConverged IT and OT visibility, sovereign deployment, and evidence mapped to the NCSC CAF and NIS2. GovernmentOn-premises sovereign deployment, a 24/7 agentic SOC, and evidence for GovAssure and the NCSC CAF. Energy & UtilitiesSCADA and substation visibility across dispersed estates, with NERC CIP and CAF evidence as an output.

Talk to someone who knows your sector

Tell us what you are protecting — the IP, the plant or the trial — and where you feel exposed. We will map it to the right capabilities and set up a walkthrough.

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