AI Safety Validation for Pharmaceutical & Biotech
FDA Submission Support • Bias Testing • Clinical AI Safety
AI-discovered drugs and clinical AI systems must pass rigorous FDA scrutiny. We help pharma companies validate their AI models for safety, bias, and regulatory compliance before submission.
The FDA Challenge
Average cost to bring one drug to market
Tufts CSDD, 2023
Of drug candidates fail in clinical trials
FDA, 2024
Average drug development timeline from discovery to approval
PhRMA, 2024
🚨 FDA rejected 3 AI-discovered drugs in 2023 due to insufficient AI validation and bias concerns.
Why Pharma AI Validation Matters
Real consequences of poor AI validation in drug discovery:
Insufficient AI validation leads to pre-market rejections
Cost: 2-5 years delay + $100M+ in lost development costs
Biased AI excludes patient populations from treatment benefits
Impact: Lawsuits, recalls, FDA enforcement, damaged reputation
Average cost of failed Phase 3 clinical trial
Cause: AI models not validated across diverse populations
Comprehensive AI Validation for Pharma
FDA-aligned testing for drug discovery AI and clinical decision support
AI Drug Discovery Validation
Validate AI models for molecular design, target identification, and compound screening.
- • Molecular structure prediction accuracy
- • False positive/negative rates
- • Generalization across drug classes
- • Training data quality & lineage
Bias & Fairness Testing
Test AI models for bias across patient demographics and disease populations.
- • Demographic parity analysis
- • Performance across race, age, sex
- • Subgroup validity testing
- • Health equity assessments
Clinical AI Safety
Safety validation for AI-powered diagnostic tools and clinical decision support.
- • Failure mode & effects analysis
- • Edge case testing
- • Safety case development
- • Post-market surveillance setup
FDA Compliance Documentation
Complete documentation packages for FDA pre-market submissions.
- • Algorithm validation protocols
- • Clinical evaluation reports
- • Risk management files
- • 510(k) or PMA documentation
Robustness & Reliability
Test AI model performance across diverse conditions and edge cases.
- • Out-of-distribution detection
- • Sensitivity analysis
- • Reproducibility validation
- • Performance monitoring
Regulatory Strategy
Navigate FDA pathways and global regulatory requirements.
- • FDA guidance interpretation
- • Regulatory pathway selection
- • EMA, PMDA alignment
- • Pre-submission meetings prep
Our FDA Validation Process
Regulatory Assessment
Determine FDA pathway (510(k), De Novo, PMA) and applicable guidance documents.
Validation Testing
Execute comprehensive test protocols: bias, safety, robustness, clinical validity.
Documentation
Prepare FDA submission package with validation reports and risk management.
Submission Support
Support your team through FDA review, answer questions, achieve approval.
What You Receive
Algorithm Validation Report (100-200 pages)
Comprehensive validation per FDA guidance on Software as Medical Device (SaMD)
Bias & Fairness Assessment
Demographic subgroup analysis with statistical validation across populations
Clinical Evaluation Report
Clinical validity and utility assessment per FDA expectations
Risk Management File (ISO 14971)
Complete risk analysis, mitigation strategies, and residual risk justification
FDA Submission Package
510(k), De Novo, or PMA documentation ready for submission
Post-Market Surveillance Plan
Continuous monitoring framework for post-approval performance tracking
Investment & Timeline
AI Model Validation
- Single AI model validation
- 8-12 weeks timeline
- Validation report + bias testing
- Risk management file
Full FDA Submission
- Complete 510(k) or PMA package
- 12-16 weeks timeline
- Full validation + clinical evaluation
- FDA submission support included
- Regulatory strategy consulting
Enterprise Program
- Multiple AI systems validation
- Pipeline support (preclinical → approval)
- Post-market surveillance
- Ongoing regulatory support
Custom packages available for biotech startups and large pharma enterprises.
Schedule a consultation to discuss your needs →Get FDA Approval. Deploy Safe AI in Healthcare.
Book a consultation to discuss your FDA submission timeline and validation requirements.
Request FDA Validation AssessmentConfidential • Clinical expertise • Regulatory fluency • Fast response