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Nine 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 — Fractional Leadership New offering

Fractional IT Quality, Security & Compliance Leadership

Fractional & interim leadership · GxP · HIPAA · SOX · NIST · ISO 27001

Most growing life sciences, healthcare, and defense suppliers reach a point where they need a Senior Director of IT Quality, Security, and Compliance — but not forty hours a week of one. Hiring full time means a long search, a six-figure package, and a fixed cost that lands well before the workload justifies it.

A fractional engagement gives you that leadership on a defined, retained basis: an agreed commitment each month — typically around a quarter of a full-time role — a written remit, and a named senior practitioner personally accountable for the outcome. You get the judgement, the regulator-facing credibility, and the decisions without carrying the headcount.

This is the same work Ope Odusan did as Head of IT Compliance at Myovant Sciences and Director of IT Digital Quality & Compliance at AbbVie — scaled to the size of your programme rather than the size of an org chart.

We price this as a monthly retainer rather than by the hour, and we will work within your budget. Tell us what you are able to allocate and we will tell you honestly what it buys and what it does not — a smaller commitment that is well scoped beats an ambitious one that stalls.

What we deliver

  • Ownership of your IT quality, security, and compliance programme
  • Regulator, auditor, and customer-facing representation
  • Policy, SOP, and control framework governance
  • Risk register ownership and executive reporting
  • Vendor and third-party risk oversight
  • Change Control Board and governance forum chairing
  • Direction and mentoring for your existing IT and QA staff
  • Board and audit-committee reporting
Common use cases

Preparing for an FDA, EMA, or customer audit; diligence for a funding round or acquisition; covering a departure or parental leave; standing up a programme before you are ready to hire; or giving an overstretched IT team senior air cover when a regulator starts asking questions.

Typical outcome

The seniority a regulator expects to see, at a predictable monthly cost that fits the budget you have — with no recruitment cycle and no long-term commitment.

Email Ope directly

Goes straight to the practice lead — not a sales queue.

02 — Quality & Validation

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.

03 — IT Compliance

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.

04 — Cybersecurity

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
05 — Offensive Security

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
  • Prioritized remediation roadmap and 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.

06 — Defense & CUI

NIST 800-171 & CMMC 2.0 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.

07 — Cloud Governance

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
08 — Laboratory Informatics

LIMS, ELN & CDS 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
09 — Privacy & Data

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 project engagements fall into one of three structures below, billed at our standard advisory rate of $150 per hour. Fractional leadership is different: it is retained monthly and priced to your budget.

Model A

Fixed-scope Project

Defined deliverable, clear acceptance criteria, milestone billing. Best for one-time implementations, validations, audits, or assessments.

Defined SOWMilestone billing
Model B

Retainer Advisory

Monthly hours pool for ongoing program support — ideal for fractional compliance officer coverage, ongoing audit readiness, or post-implementation governance.

Monthly hoursOngoing
Model C

Time & Materials

Hourly billing against a not-to-exceed cap. Used for discovery work, scoping studies, and short-cycle remediation efforts.

HourlyNTE cap

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