Computer System Validation
End-to-end CSV lifecycle for GxP systems aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11. URS, IQ/OQ/PQ, traceability, and validation summary reports.
— Established 2025 · California
Compliance,
engineered.
Strategic IT, Quality, Compliance, and Security consulting for life sciences, healthcare, and FDA-regulated industries. Built on 25+ years of leadership inside AWS, AbbVie, Gilead, and Johnson & Johnson.
25+
Years in regulated technology leadership
3
Active enterprise client engagements
$150/hr
Transparent, single hourly rate
0
Major audit findings under our governance
— What we do
Six practices,
one operating standard.
We design, implement, and validate the systems and controls that let regulated organizations move fast without losing inspection readiness. Every engagement is anchored in proven methodology and senior, hands-on delivery.
GRC Program Build & Audit Readiness
Enterprise governance frameworks, policies, SOPs, ITGC/ITAC libraries, and inspection-readiness programs designed to withstand FDA, EMA, and SOX scrutiny.
Security Governance & Risk
NIST CSF and ISO 27001-aligned programs, third-party risk, vulnerability management oversight, privacy programs (OneTrust), and customer security assurance.
Multi-Cloud Compliance Architecture
Compliant AWS, Azure, and GCP architectures with automated monitoring for regulated workloads — including segregated EU environments under GDPR.
LIMS, ELN & CDS Implementation
Hands-on implementation and validation of LabVantage, BIOVIA, LabWare, Empower, NuGenesis, and TrackWise across pharma, biotech, and CDMO environments.
Privacy Program Management
GDPR, CCPA, and HIPAA privacy programs with OneTrust implementation, consent management, data subject rights, and DPIA execution.
— Industries we serve
Pharmaceutical
Biotechnology
Medical Devices
CDMO / CMO
Healthcare
Clinical Research
— Why Nasudo
Senior leaders.
Senior delivery.
Most consulting firms send senior leaders to win the work and junior staff to deliver it. We don't. Every Nasudo engagement is led by Ope Odusan personally — drawing on a quarter-century of building compliance and security programs inside the world's most heavily regulated companies.
That's why our clients include Fortune 500 pharmaceutical companies and growth-stage biotech CDMOs alike: they get the same caliber of leadership, the same rigor, and the same accountable senior partner from kickoff to inspection.
We work hourly at $150 per hour. No multi-tier billing schemes. No surprise pass-throughs. Just transparent, senior advisory work — designed to be the most valuable hour in your week.
More about our practice →— How we engage
A clear path
from inquiry to outcome.
We've removed the friction that slows most consulting engagements. From first conversation to signed SOW, you can be moving in days, not months.
Discovery
30-minute call to understand your regulatory exposure, current state, and the outcome you're trying to reach.
Rough Estimate
Within 48 hours: a written rough order of magnitude estimate covering hours, cost, timeline, and deliverables.
Statement of Work
Detailed SOW with milestones, success criteria, and acceptance gates. Reviewed and signed under California LLC.
Delivery
Weekly check-ins, traceable artifacts, and inspection-ready documentation from day one through closeout.
— Ready when you are
Let's talk about your
next inspection.
Whether you're standing up a LIMS, preparing for an FDA audit, or building a compliance program from zero — we can help you scope it cleanly.