Your compliance partners should know the rules—not just follow them.
Our executives were key contributors to the FDA's CSA guidance—FICSA co-founders, behind the guidance your auditors reference. When we advise on AI governance, validation strategy, or regulatory modernization, we helped shape what your auditors use.
The biggest compliance risk you face isn't a specific gap in your QMS or validation documentation. It's that your program was built to pass audits—not to scale. Peers who modernized 18 months ago are moving 3× faster through FDA validation.
What your program looks like after a strategic engagement.
Your next inspection is a non-event
Evidence assembled in minutes. AI governance framework documented and defensible before the auditor asks.
Your compliance scales with your business
Expert judgment embedded in systems and processes — not trapped in 2–3 people who could leave.
Your quality team operates compliance — not proves it
Continuous assurance replaces the quarterly audit scramble. Your best people focus on what matters.
You have one partner who sees the whole picture
From strategy through staffing through managed services through AI tools — one trusted partner, not five vendors.
Your compliance program was designed to pass audits. Not to scale.
Expert judgment is concentrated in 2–3 trusted individuals. Frameworks live in binders that don't survive the people who wrote them. And now AI governance is on the list—without a methodology your current consulting partners have.
CSA guidance is final—most programs haven't caught up
Most consulting firms were built for the legacy CSV era. Their SOW structures reflect 2019, not today's CSA + AI governance reality.
EU AI Act timelines are firming up
Conformity assessments and human oversight documentation need to be in place before market entry—not assembled after an inquiry.
ISO/IEC 42001 is the new audit question
The AI Management System standard is what inspectors are beginning to reference. Almost no organization has a certified program yet.
QMSR is live and most programs aren't ready
The Quality Management System Regulation is in effect. Programs designed for the old Part 820 require strategic updates, not minor patches.
Tribal knowledge walks out with your best people
If your two most senior quality experts left next month, how long before your compliance program breaks? Most teams know the answer.
Generic consultants don't know your tools
They send validators who learn Veeva and Polarion on your project. You need people who already know CSA, GAMP 5, and how your stack actually works.
Five strategic consulting practice areas.
Each practice area connects to the others. A CSA transformation naturally surfaces AI governance gaps. An AI governance engagement reveals data integrity exposures. We give you the full picture—not a narrow SOW.
AI Governance and Compliance Modernization
ISO/IEC 42001-aligned frameworks, FDA AI guidance interpretation, model validation protocols, and ongoing compliance monitoring—built before your next inspection asks.
CSA Program Design and Transformation
From CSA strategy through execution—risk-based validation, CSA-aligned testing, critical thinking documentation, and retrospective remediation for legacy programs.
Regulatory Strategy and Inspection Readiness
FDA, EU MDR/IVDR, EU GMP Annex 11, ISO 13485—our team has been in the audit room for 25 years. We translate regulatory evolution into defensible programs.
Digital Transformation and Platform Advisory
Polarion ALM strategy, Veeva Vault optimization, QMS selection and migration—guided by experts who have run these programs at scale in regulated environments.
Which situation describes your organization?
"How do we govern the AI tools we're already using before the FDA asks?"
- Current consulting partners were built for CSV—figuring out AI governance alongside you
- Need an expert who has been in the FDA's room—not reading the guidance for the first time
- Existing stack: Veeva, MasterControl, or similar established platforms
"Our compliance program is held together by spreadsheets and three people."
- Need an expert-led program that modernizes what's broken without disrupting what's working
- Compliance program designed for an earlier stage of the business
- Board or investors asking questions your team doesn't have written answers to yet
We didn't just read the guidance. We helped write it.
Our executives were key contributors to the FDA's CSA guidance—FICSA co-founders, behind what your auditors reference. We're ISPE GAMP 5 Second Edition co-authors. We hold ISO/IEC 42001 certification—the only certified AI Management System in life sciences compliance.
FICSA co-founders
We helped shape the FDA's CSA guidance your auditors reference. When we advise on CSA, we draw on the same framework the FDA uses to evaluate your program.
ISO/IEC 42001 certified
Only ISO/IEC 42001-certified AI Management System in life sciences compliance. We govern our own AI under the same standard we recommend to clients.
ISPE GAMP 5 co-authors
Second Edition steering committee. The validation methodology we apply to every engagement is the same one GAMP 5 encodes as the industry standard.
Outcome-based model
We don't bill for deliverables that don't move your program forward. Every engagement has a defined outcome and a handoff that leaves your team more capable.
Proprietary AI tools
CLAiRE AI Agentic Platform for continuous compliance intelligence (Audit Trail Review, Quality Reviews, Compliance Assessments, Continuous Monitoring), MAiGRATE for regulated data migration, and iQuality for AI-native QMS — all built in-house, all governed under ISO/IEC 42001.
Bridge to technology
Every strategic engagement connects to iQuality or CLAiRE AI Agentic Platform for sustained compliance after the consulting engagement ends.
Strategic Consulting engagements surface compliance gaps that connect directly to CLAiRE AI Agentic Platform for continuous audit trail coverage, iQuality for AI-native QMS deployment, and Managed Services for ongoing governance after the engagement ends.
Book a Free AI Readiness Assessment.
45 minutes with a senior expert—not a sales rep. We score your AI governance posture, validation approach, and inspection readiness. Written risk brief. No commitment.
Book Your Free Assessment