About GxP Agents
Transforming how life sciences organizations leverage AI across regulated workflows -- from quality and regulatory to clinical development and beyond.
Our Mission
We believe AI should amplify human expertise in regulated environments, not replace it.
GxP Agents brings purpose-built AI to life sciences, designed from the ground up for the unique challenges of regulated industries. Every agent we build operates within a framework of human oversight, regulatory alignment, and operational transparency.
Our three-tier maturity model -- assistive, generative, and predictive -- ensures organizations can adopt AI at the pace that suits their readiness, culture, and regulatory requirements.
Human-in-the-Loop
AI augments decisions, humans remain accountable
Regulatory First
Built within GxP, 21 CFR Part 11, and ICH frameworks
Domain Expertise
Deep knowledge across all 8 regulated domains
Progressive Maturity
From assistive automation to predictive intelligence
USDM Life Sciences Partnership
GxP Agents is born from a strategic collaboration with USDM Life Sciences, a trusted leader in regulated industry compliance and digital transformation.
USDM Life Sciences
Trusted Compliance Partner
USDM Life Sciences brings decades of hands-on experience across GxP compliance, cloud validation, data integrity, and digital transformation in the life sciences industry. Their deep domain expertise ensures every AI agent is grounded in real operational challenges and regulatory requirements.
Why This Partnership Matters
Regulatory Credibility
Solutions designed by practitioners who have navigated FDA, EMA, and global regulatory landscapes firsthand.
Operational Realism
AI agents built for the workflows and bottlenecks that exist in actual life sciences operations, not theoretical scenarios.
Validation Expertise
Every solution is designed with validation, qualification, and audit-readiness built in from day one.
Industry Trust
USDM has served hundreds of life sciences companies, from emerging biotechs to global pharma enterprises.
Contributors
The leadership and domain experts behind the GxP Agents white paper and platform vision.
John Petrakis
Chief AI Officer
David Blewitt
VP Cloud Compliance
Jennell Botero
Principal Consultant
Hovsep Kirikain
VP Strategy and Operations
Mark Ohrvall
VP Delivery Operations
Lisa Om
VP Marketing & Communications
Brian Rankin
Head of Cybersecurity Services
Brittany Walker
Principal Consultant
Buy vs. Build vs. Augment
Choosing the right AI adoption strategy depends on your organization's unique needs, existing infrastructure, and competitive priorities.
Buy
When speed, regulatory alignment, and standardization are paramount. Pre-built solutions offer proven compliance frameworks, faster time to value, and reduced implementation risk for standard industry workflows.
Best For
- Standardized regulatory workflows
- Rapid deployment requirements
- Proven compliance frameworks needed
- Lower total cost of ownership
Build
When the process is a source of competitive differentiation. Custom-built solutions allow for proprietary logic, unique data models, and tailored workflows that become strategic assets.
Best For
- Proprietary processes and IP
- Unique competitive advantage
- Highly specialized data models
- Full control over architecture
Augment
When existing platforms provide foundational AI capabilities that can be extended. Leverage platform investments with targeted enhancements to fill specific gaps and accelerate AI adoption.
Best For
- Existing platform investments
- Incremental AI enhancement
- Extension of current capabilities
- Balanced cost and customization
Partner With Us
Whether you are just starting your AI journey or looking to scale intelligent automation across your organization, we are here to help.