Generative AI for Regulatory Documentation Accelerator

Regulatory reporting is a major bottleneck for life sciences organizations, consuming thousands of hours in manual FDA submissions, compliance documentation, and audit preparation. This 4-week POC uses AWS Bedrock & Textractto automate the generation, extraction, and formatting of compliance documents, reducing manual workload and improving accuracy. What’s Included: • AI-Powered Document Generation – Automates FDA submissions using AWS Bedrock NLP models. • Automated Compliance Auditing – Uses Textract to extract key regulatory insights from unstructured data. • Structured, Audit-Ready Reports – Auto-formats reports for HIPAA, GxP, and GDPR compliance. • Next Steps Roadmap – Plan for scaling AI-powered regulatory automation in your AWS environment.