Accelerate Drug Development withValidated AI Documentation
From R&D to regulatory submission, manage GxP documentation, batch records, and clinical trials with 21 CFR Part 11 compliant AI automation.
21 CFR Part 11 Compliance Ready
Complete validation documentation package available upon request
AI Copilots for Pharma & Life Sciences
Validated AI assistants trained on pharmaceutical regulations, GxP requirements, and life sciences best practices.
Regulatory Affairs Copilot
Navigate FDA, EMA, PMDA requirements and submission planning
Quality Assurance Copilot
CAPA management, deviation handling, and audit preparation
Manufacturing Copilot
Batch record review, process monitoring, and release decisions
Clinical Operations Copilot
Trial documentation, site management, and TMF compliance
Global Regulatory Compliance
Built for the most demanding regulatory environments in the world.
FDA 21 CFR Part 11
Electronic records and signatures
FDA 21 CFR Part 211
Current Good Manufacturing Practice
ICH Guidelines
Q7, Q9, Q10 quality standards
EMA Regulations
European Medicines Agency compliance
PMDA Standards
Japan pharmaceutical regulations
GxP Compliance
GMP, GLP, GCP, GDP requirements
Transforming Pharma Documentation
See how pharmaceutical companies accelerate drug development with AI-powered documentation.
Regulatory Submission Management
Managing 100,000+ page NDAs/BLAs with version control across global regulatory agencies (FDA, EMA, PMDA) while maintaining eCTD format compliance.
AI-powered document assembly with automatic eCTD formatting, cross-reference management, and regulatory intelligence for submission planning.
Key Benefits
Batch Record & Manufacturing Documentation
Paper-based batch records leading to data integrity issues, manual review bottlenecks, and delays in batch release.
Electronic batch records with real-time exception handling, automated review workflows, and complete audit trails for Part 11 compliance.
Key Benefits
Quality Document Control
Managing thousands of SOPs, specifications, and controlled documents with complex approval workflows and training requirements.
Intelligent document control with automated routing, training matrix integration, and version comparison for change impact assessment.
Key Benefits
Clinical Trial Documentation
Coordinating investigator site files, informed consent tracking, and protocol amendments across global clinical sites.
Centralized trial master file with AI-powered completeness checks, site compliance monitoring, and inspection readiness dashboards.
Key Benefits
Measurable Impact on Drug Development
Ready to Accelerate Drug Development?
Join pharmaceutical companies transforming their documentation with validated AI.