Intelligence. Expertise. Execution.
Your compliance program was built to pass audits.
We build programs that drive decisions.
Compliance Group partners with life sciences organizations to meet regulatory demands, boost operational efficiency, and modernize compliance through expert talent, proven frameworks, and AI-driven technology.
The Industry Shift
Competitors who adopted CSA 18 months ago are moving 3× faster through FDA validation. The ones who waited are now in remediation. Which path are you on?
25+
Years in Quality & Compliance
CSV, CSA, AI governance across biotech, pharma, medtech
60+
Life Sciences Clients
60+ life sciences organizations on multi-year programs
FDA
Key Contributor of CSA Guidance
FDA–Industry CSA Team (FICSA) co-founders
AI‑native
Proprietary Tooling
CLAiRE, MAiGRATE & iQuality™ built for life sciences
What success looks like
Four outcomes your quality team will feel in 90 days.
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.
Four service lines
People, process, and AI-driven technology, in one partner.
Four integrated service lines, one delivery model. Every Compliance Group engagement connects strategy, staffing, governance, and AI tools, so you get compounding value, not disconnected deliverables.
01 / Strategic Consulting
Deep process expertise, risk-based strategy, AI governance, and digital transformation.
For life sciences teams that need more than a binder. We design programs that hold up under scrutiny, and scale after we leave.
02 / Specialized Resourcing
Domain-vetted life sciences talent delivered the way you need it.
On-site, remote, nearshore, offshore, or fractional. CSA, Quality, GxP Systems Experts, Manufacturing, Clinical, pre-vetted for GxP fluency.
03 / Managed Services
Outsourced Quality & Compliance programs for Life Sciences, supporting Validation, CSA, AI Governance, Veeva, and Polarion.
40–60% below traditional consulting rates. Zero audit findings across managed programs. SLA-backed delivery.
04 / OCM & Microlearning
Organizational change management and role-based microlearning that makes system & process adoption stick.
Across CSA & AI Governance, Veeva, Polarion, QMS, LIMS, and clinical systems. Built by compliance and UX experts. Training that transfers.
Two types of life sciences organizations come to us.
Which situation describes your organization?
Established Quality Program
You have QMS platforms. You need AI governance.
$250M+ revenue · Established QMS/DMS/VLMS
- AI governance gap: no documented framework before the FDA asks
- Audit trail review is manual and sample-based (90-day blind windows)
- Board is asking about AI governance today
- Existing stack: Veeva, MasterControl, or similar
Compliance Group entry: AI governance program → CLAiRE AI Agentic Platform → Managed Services
Scaling Life Sciences Company
You’re scaling fast. Your compliance hasn’t kept up.
$25M–$250M revenue · Building or rebuilding
- Running on spreadsheets or legacy tools that haven’t scaled
- 2–3 people hold everything together; one departure = a crisis
- Compliance hasn’t kept pace with business growth
- Need modern QMS/DMS without an 18-month implementation
Compliance Group entry: Strategic consulting → Managed Services → iQuality AI-native QMS platform
Years in quality & compliance
Regulated client organizations
Projects delivered globally
Client revenue generated
Certifications
ISO/IEC 42001:2023 · SOC 2 Type 2 · ISO/IEC 27001:2022
ISO/IEC 42001:2023 Certified
The only ISO/IEC 42001-certified AI Management System in life sciences compliance. Every AI recommendation is explainable, traceable, and audit-ready.
SOC 2 Type 2 Compliant
Independently audited controls. Proven operational effectiveness. Security, availability & confidentiality assured.
ISO/IEC 27001:2022 Certified
International information security standard. Risk-based security management. Strong data protection for regulated environments.
Certifications
Book a Free Assessment.
45 minutes with a senior expert, not a sales rep. We score your governance posture, validation approach, and inspection readiness. Written risk brief. No commitment.