AIG×P
Advisory
Pharmaceutical AI Governance

Navigate FDA & EU AI Act Compliance with Confidence

Expert guidance for small and medium pharmaceutical companies implementing AI governance frameworks that ensure regulatory compliance and business success.

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20+ Years
Pharmaceutical Development
👨‍🏫
Teaching Faculty
AI Governance Courses
🔬
AI Systems
Built for Clinical Trials
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Statistical Validation
Model Assessment Expert

Helping Pharmaceutical Companies Implement AI with Confidence

With deep pharmaceutical development expertise and hands-on AI systems development, we help pharmaceutical companies navigate the complex landscape of AI governance and regulatory compliance.

Navigate Regulations

  • FDA AI guidance interpretation
  • EU AI Act compliance roadmaps
  • Global regulatory coordination
  • Risk classification frameworks
  • Submission strategy development

Implement Governance

  • AI governance frameworks
  • Policy and procedure development
  • Model validation protocols
  • Risk management systems
  • Documentation standards

Ensure Compliance

  • Pre-submission readiness audits
  • FDA/EMA submission support
  • Validation documentation
  • Quality system integration
  • Ongoing compliance monitoring

Advisory Services

Getting Started

AI Readiness Assessment

Rapid evaluation of your compliance gaps and strategic roadmap for AI governance implementation.

Starting at $2,500
  • 60-minute consultation
  • Current state analysis
  • Gap identification
  • Prioritized recommendations
  • Professional report
Implementation

AI Governance Framework

Complete governance system designed for FDA and EU AI Act compliance with proven methodologies.

  • 10-12 week implementation
  • Policies and procedures
  • 30+ customized templates
  • Validation protocols
  • Training materials
  • FDA/EMA readiness
Implementation

Clinical Trial AI Optimization

Implement AI in clinical trials with proper governance, validation, and regulatory strategy.

  • 8-10 week engagement
  • Use case validation
  • Vendor integration oversight
  • Protocol methodology
  • Statistical validation
  • FDA submission support
Implementation

Data Governance for AI

Transform fragmented data systems into AI-ready infrastructure with proper governance and quality controls.

  • 9-10 week program
  • Data quality audit
  • FAIR & ALCOA compliance
  • Governance framework
  • Integration roadmap
Implementation

Regulatory Submission Support

Expert guidance for FDA/EMA submissions involving AI with comprehensive documentation and strategy.

  • 8-10 week preparation
  • Submission strategy
  • Documentation package
  • Validation evidence
  • Agency question support
  • Meeting preparation
Ongoing Support

Fractional AI Governance Officer

Ongoing governance leadership without the cost of a full-time hire. Expert guidance when you need it.

  • 10-15 hours monthly
  • Committee participation
  • Use case reviews
  • Policy updates
  • Regulatory monitoring
  • Executive reporting

How We Work Together

1

Free Assessment

30-minute consultation to understand your AI governance challenges and objectives.

2

Tailored Proposal

Clear scope, deliverables, timeline, and investment based on your specific needs.

3

Collaborative Implementation

Work closely with your team to implement proven frameworks and build internal capability.

4

Ongoing Support

Optional retainer relationships for continued guidance as regulations and needs evolve.

Recognized Expertise in AI Governance

AIGxP Advisory was founded to address a critical gap: small and medium pharmaceutical companies need expert guidance to navigate AI implementation, but most consulting firms focus exclusively on large enterprises.

With over 20 years of experience in pharmaceutical development and hands-on experience building AI systems for drug development, we bring both technical depth and practical regulatory knowledge to every engagement.

20+
Years Pharma Experience
100%
Focus on Compliance
FDA+EU
Regulatory Expertise

Ready to Implement AI Governance?

Schedule a complimentary 30-minute AI readiness assessment to discuss your specific challenges and explore how we can help.

Schedule Free Assessment

Let's Discuss Your AI Governance Needs

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Schedule Assessment

Book 30-Minute Call

AIGxP Labs, LLC
Indianapolis, Indiana