Fixed-scope Project
Defined deliverable, clear acceptance criteria, milestone billing. Best for one-time implementations, validations, audits, or assessments.
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Six practices.
One operating standard.
Every engagement is led personally by a senior practitioner, scoped against measurable outcomes, and delivered with the documentation rigor regulators expect.
— 01
Computer System Validation
GAMP 5 · 21 CFR Part 11 · EU Annex 11 · MHRA · ICH
End-to-end validation lifecycle for GxP-regulated computerized systems — including LIMS, ELN, CDS, SDMS, QMS, ERP, and laboratory instrumentation.
What we deliver: Validation Master Plans · User Requirements Specifications · Functional & Design Specifications · Installation, Operational & Performance Qualification (IQ/OQ/PQ) · Traceability matrices · Risk assessments · Validation Summary Reports.
Common use cases: New system deployment, cloud migration of validated systems, periodic review, infrastructure qualification, and remediation of validation gaps identified in internal audits or regulatory inspections.
— 02
IT Compliance & GRC Program Build
SOX · ITGC · ITAC · COBIT 5 · ITIL · Audit Readiness
We build enterprise IT compliance programs from the ground up — or remediate existing programs that have outgrown their original design. Based on 25 years of experience standing up Compliance Centers of Excellence inside companies like AbbVie and Myovant.
What we deliver: Policy and SOP libraries · ITGC/ITAC control frameworks · IT risk registers · CAPA & deviation management · Change Control Board governance · Quality metrics dashboards · Internal audit preparation · Inspection readiness assessments.
Typical outcome: A program that survives FDA, EMA, internal, and SOX audits with zero major findings.
— 03
Cybersecurity & Risk Governance
NIST CSF · ISO 27001 · HITRUST · SOC 2 · HIPAA
Strategic cybersecurity advisory grounded in CISSP-level practice and hyperscale cloud experience. We help security and compliance leaders design programs that both regulators and customer security teams will accept.
What we deliver: NIST CSF and ISO 27001 gap assessments · security policy libraries · third-party / vendor risk programs · vulnerability and penetration testing oversight · incident response governance · customer security questionnaire response programs · executive risk reporting.
— 04
Cloud Security & Governance
AWS · Azure · GCP · GovCloud · FedRAMP · GDPR
Built on direct AWS hyperscaler experience. We design and govern compliant multi-cloud architectures for regulated workloads — including segregated EU environments under GDPR and validated GxP infrastructure.
What we deliver: Cloud security architecture reviews · landing zone design · continuous compliance monitoring · automated evidence collection for audit · cloud migration governance · regulated workload isolation patterns.
— 05
Laboratory Informatics Implementation
LIMS · ELN · LES · CDS · SDMS · Instrument Integration
Hands-on implementation experience across LabVantage, LabWare, BIOVIA, Waters Empower, NuGenesis, and TrackWise — in both on-premises and SaaS deployments. Currently engaged with AstraZeneca (BIOVIA LIMS) and Bionova Scientific (LabVantage LIMS SaaS for CDMO operations).
What we deliver: Vendor selection · requirements gathering · configuration design · validation execution · instrument and barcode system integration · data migration · user training · go-live and hypercare support.
— 06
Privacy Program Management
GDPR · CCPA · HIPAA · OneTrust · DPIA
Privacy program design and OneTrust implementation experience drawn from iRhythm Technologies, where we delivered a full GDPR-compliant program including segregated EU AWS infrastructure for regulated data workloads.
What we deliver: Privacy program design · OneTrust deployment and tuning · consent management · data subject rights workflows · DPIA execution · vendor data processing assessments · privacy training programs.
— Engagement models
Three ways
to work with us.
Most engagements fall into one of three structures. All are billed at our standard advisory rate of $150 per hour.
Retainer Advisory
Monthly hours pool for ongoing program support — perfect for fractional compliance officer, ongoing audit readiness, or post-implementation governance.
Time & Materials
Hourly billing against a not-to-exceed cap. Used for discovery work, scoping studies, and short-cycle remediation efforts.
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