Fixed-scope Project
Defined deliverable, clear acceptance criteria, milestone billing. Best for one-time implementations, validations, audits, or assessments.
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Eight 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
Penetration Testing & Offensive Security
OWASP · PTES · NIST SP 800-115 · MITRE ATT&CK · OSINT
Goal-driven security testing that shows you how a real attacker would reach your most sensitive systems and data — then exactly how to close those paths. Testing is scoped to your risk, rules of engagement are agreed in writing, and findings are validated to eliminate false positives.
What we deliver: External & internal network penetration testing · web and API application testing · cloud configuration review (AWS, Azure, GCP) · social engineering and phishing simulations · vulnerability assessments · a prioritized remediation roadmap and an executive-ready report · optional re-testing to confirm fixes.
Common use cases: Annual or pre-audit testing, customer or regulator security requirements, evidence for SOC 2 / ISO 27001 / HIPAA, CMMC assessment preparation, and validation after a major release or migration.
— 05
NIST 800-171 & CMMC 2.0 Assessment & Program Management
NIST SP 800-171 · CMMC 2.0 · DFARS 7012 · SPRS · SSP & POA&M
End-to-end support for defense contractors and suppliers who must protect Controlled Unclassified Information (CUI) and meet Department of Defense cybersecurity requirements. We take you from where you are today to a defensible, assessment-ready program.
What we deliver: NIST 800-171 gap assessments against all 110 controls · System Security Plans (SSP) · Plans of Action & Milestones (POA&M) · SPRS score calculation and submission support · CUI scoping and data-flow mapping · policy and procedure development · remediation project management · CMMC 2.0 Level 1 and Level 2 readiness and pre-assessment.
Typical outcome: An accurate SPRS score, a complete evidence package, and a managed remediation plan that withstands a C3PAO assessment or a DoD audit.
— 06
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.
— 07
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.
— 08
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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