Validated.
Hardened.
Audit-Ready.
Senior cybersecurity, infrastructure, and AI consulting for pharma, biotech, medical device, and CDMOs. We modernize without breaking 21 CFR Part 11 validation. We segment OT manufacturing without halting batch records.
Why Pharma Is Different
IP Walks Out
Three Ways.
Pharma's threat surface is uniquely shaped: R&D IP theft by nation-state actors, ransomware on OT manufacturing networks that halts batch production, and supply-chain compromise through CRO and CDMO partners. Every IT change has to clear validation. Every validated system has documented change control. Skip either and you've created a regulatory finding that costs more than the original problem.
We work inside GAMP 5 categories, write IQ/OQ/PQ docs that hold up under FDA inspection, and modernize without invalidating the systems you've already qualified.
Compliance We Map To
Validated To
The Word.
21 CFR Part 11
Electronic records, electronic signatures. ER/ES posture for clinical, manufacturing, and quality systems.
GAMP 5
Risk-based validation by category 1-5. URS / FS / DS / IQ / OQ / PQ documentation.
EU GMP Annex 11
Computerized systems used in regulated manufacturing. EMA inspection readiness.
ICH Q9
Quality risk management. Data integrity (ALCOA+) for batch records and lab systems.
FDA Cybersecurity Guidance
Premarket and postmarket cybersecurity for medical device manufacturers (510(k) ready).
HIPAA + State Privacy
PHI in clinical trial systems, patient-recruitment platforms, real-world data partnerships.
What We Ship For Pharma
Modernize
Without
Revalidating Everything.
AD Hardening & Network
Active Directory rebuilds that preserve GxP validation, segmented OT manufacturing networks.
See more → Cybersecurity24/7 Threat Response
Nation-state R&D targeting, CRO partner breach detection, manufacturing OT anomaly hunt.
See more → InfrastructureValidated System Implementation
LIMS, QMS, eDMS, eTMF deployments with IQ/OQ/PQ packs your auditors actually accept.
See more → InfrastructureM&A IT Due Diligence
Pharma acquisitions, CDMO integrations, asset-deal carveouts. Validation lineage preserved.
See more → ConsultingAI in Drug Discovery
ML model governance for target ID, ADMET prediction, clinical trial enrollment, ICH E6 R3 alignment.
See more → CybersecurityPenetration Remediation
Pentest + remediation for clinical, manufacturing, and commercial environments. Reports auditors trust.
See more →Receipts
Real Work.
Real Pharma.
FAQs for
Pharma
Buyers
Don't see your question? Just ask.
Will an AD rebuild break our GxP-validated systems?
Not if it's planned right. We map every validated system's authentication dependencies, build the new AD in parallel, run validation in the new domain before cutover, and execute a single coordinated cut with rollback in place. We've done this for sites running LIMS, MES, EBR, and SCADA without triggering a revalidation event.
Do you write GAMP 5 validation packs?
Yes. URS, FS, DS, IQ, OQ, PQ. All written to your SOP standards and ready for FDA, EMA, or internal QA review. We work alongside your validation team, not around them.
How do you handle data integrity / ALCOA+ for systems we already own?
We start with a data flow map across every system that touches batch records, deviations, or analytical data, then identify the points where ALCOA+ attributes (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available) are weakest. The output is a prioritized remediation plan with audit-trail integrity at the top.
Can you support medical device cybersecurity premarket submissions?
Yes. We help device manufacturers assemble the cybersecurity documentation FDA expects in 510(k) / De Novo / PMA submissions: threat model, SBOM, vulnerability mgmt plan, post-market cybersecurity plan. Tied to AAMI TIR57 and IEC 81001-5-1.
Modernize
Without
The Fear.
Senior consultants who actually understand GxP. Talk through your situation. Usually 30 minutes is enough to know whether we're the right fit.
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