Transforming Pharmaceutical Operations With Enterprise AI
Purpose-built intelligence for the most critical quality, compliance, manufacturing, and supply-chain challenges
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Supply Chain Management
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Manufacturing
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Process Validation
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Regulatory & Compliance
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Quality Assurance
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Competitive Intelligence
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Clinical Operations
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SOP & Regulatory Gap Analysis
• Supply Chain Management • Manufacturing • Process Validation • Regulatory & Compliance • Quality Assurance • Competitive Intelligence • Clinical Operations • SOP & Regulatory Gap Analysis
BioPhy delivers a suite of modular AI solutions across Pharma, each built to solve a critical operational challenge and turn months of manual work into minutes of actionable insights.
Built by the team behind J&J’s $100M+ AI savings. BioPhy is purpose-built to modernize Pharma’s compliance and operations infrastructure.
Not a science problem - a systems problem…
Legacy systems are holding pharma back - not because innovation is lacking, but because infrastructure is decades behind.
Regulatory Risk
76%
of FDA warning letters cite documentation errors
Financial Impact
$40M
per site/year is spent on manual quality control
Operational Drain
30%
of staff time is lost to documentation, not science
Three Flagship Modules. One Intelligent Platform. Built to Scale.
Regulatory Gap Analyzer
Automatically identifies misalignments between SOPs and regulations.
Compliance risk scoring
Remediation recommendations
65% reduction in manual review
Ideal for Quality Operations, Document Control, and Site Leads
SOP Consolidator
Eliminates document duplication across departments and regions.
Document similarity analysis
Cross-regional consistency checks
Version control monitoring
Perfect for Manufacturing, Validation, Engineering Teams
Validation Accelerator
Streamlines IQ/OQ/PQ validation cycles saving months per product.
Automated protocol generation
Traceability matrix creation
Real-time validation monitoring
Essential for expediting product launch timelines
Client Use Case
Our top-10 Pharma client faced $50M/day in manufacturing delays due to slow, manual internal solutions that resulted in regulatory and process violations. BioPhy stepped in and automated validation and documentation - cutting months of work to just hours, avoiding extremely costly downtime with no disruption.
“BioPhy improved our research and development speed and simplicity by at least 100x”
Large US Pharma
Client Quotes
“BioPhy has quickly become the leading AI partner we bring to our life sciences clients”
Big 3 Consulting Firm
“BioPhy has delivered a set of solutions with a level of value no one else has provided”
Large European Pharma
Meet the Team
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Dave Latshaw II, Ph.D.
Chief Executive & Scientific Officer
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Caitlin Jaye-Yan
Chief Compliance Officer & General Counsel
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Lewis Katz
Chief Operating Officer
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Daniel Sciubba, MD
Chief Medical Officer
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![Scott Kobayashi]()
Scott Kobayashi
Senior Vice President
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![Tejas Reddy]()
Tejas Reddy
Quantitative Data Scientist
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Liviu Chiriac
Vice President of Engineering
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Ashok Kadari
Full-stack Developer & Data Engineer
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Ari Spiesberger
Senior Research Scientist
