Fractional IT Quality, Security & Compliance Leadership
Senior compliance, quality, and security leadership on a fraction of a full-time hire — the same authority in the room, sized to what you actually need.
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.
0+
Years in regulated technology leadership
0
Active enterprise client engagements
0
Practices across quality, security & compliance
0
Major audit findings under our governance
What we do
Nine practices,
one operating standard.
From fractional senior leadership to hands-on delivery, we design, implement, and validate the systems and controls that let regulated organizations move fast without losing inspection readiness.
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.
IT Compliance & GRC Program Build
Enterprise governance frameworks, policies, SOPs, ITGC/ITAC control libraries, and inspection-readiness programs designed to withstand FDA, EMA, and SOX scrutiny.
Cybersecurity & Risk Governance
NIST CSF and ISO 27001-aligned programs, third-party risk, vulnerability management oversight, privacy programs, and customer security assurance.
Penetration Testing & Offensive Security
Network, web, API, and cloud penetration testing with social engineering simulations — validated findings, a prioritized remediation roadmap, and optional re-testing to confirm fixes.
NIST 800-171 & CMMC 2.0 Program Management
CUI scoping, NIST 800-171 gap assessments, SSP and POA&M development, SPRS scoring, and managed remediation to reach CMMC 2.0 Level 1 and Level 2 assessment readiness.
Cloud Security & Governance
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
Framework coverage
The standards we
work in every day.
Depth across the regulatory, security, and quality frameworks that define the regulated technology stack — not a checklist, but working, hands-on command of each.
Regulatory & Quality
95%
21 CFR Part 11EU Annex 11GAMP 521 CFR 210/211/820ICHMHRAISO 13485ISO 17025
Security & Governance
92%
NIST CSFNIST 800-53NIST 800-171ISO 27001SOC 2HITRUSTFedRAMPCOBIT 5
Privacy & Data Protection
88%
GDPRCCPAHIPAAHITECHOneTrustDPIA
Cloud & Infrastructure
90%
AWS GovCloudMicrosoft AzureGoogle CloudHybrid cloudSplunkSecuronix
Why Nasudo
Senior leaders.
Senior delivery.
Zero
major findings across FDA, EMA, and SOX audits under our governance
48 hrs
from discovery call to written rough-order-of-magnitude estimate
1:1
principal-led delivery — the person who scopes it is the person who builds it
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 publish our project rate — $150 an hour — because you should know what an hour costs before you buy one. No multi-tier billing schemes, no surprise pass-throughs. Fractional and retained engagements are priced monthly instead, and we will work within the budget you have.
Our products
Expertise,
turned into software.
We don't just advise — we build. Nasudo Group develops products that turn decades of regulatory experience into measurable, audit-ready compliance intelligence.
Compliance intelligence for GMP training
An intelligent GMP training and competency platform for pharma, biotech, and medical device companies — turning training into verified, inspection-ready competency aligned to 21 CFR 211.25(a).
Our next-generation AI platform
Our upcoming applied-AI platform for regulated and quality-driven organizations, currently under active development. Preview the early site and register your interest.
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.
STEP 01
30 minutes
Discovery
A short call to understand your regulatory exposure, current state, and the outcome you're trying to reach.
STEP 02
48 hours
Rough Estimate
A written rough order of magnitude estimate covering hours, cost, timeline, and deliverables.
STEP 03
3–5 days
Statement of Work
Detailed SOW with milestones, success criteria, and acceptance gates. Reviewed and signed under California LLC.
STEP 04
Ongoing
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.