⚕️ the world's first unified, lifecycle-centric regulatory framework specifically designed for autonomous AI agents in medical environments (270+ requirements, 3 risk categories).

FDA CSA-compliant test automation framework. Built with Python and Playwright to automate pharmaceutical risk assessments, ALCOA+ evidence capture, and 21 CFR Part 11 validation workflows.

Automated lab temperature monitoring deployed on a Raspberry Pi with FDA 21 CFR Part 11 compliant audit trails. Replaces ~250 hours/year of manual logging.

# Medical-Grade Graviton Safety System

Official implementation: A Clinical Informatics Framework for Myeloid Oncology. Integrates Scalable AI (GBDT, LSTM) and LLMs (Agentic AI) for precision oncology trial management, patient stratification, and automated FDA 21 CFR Part 11 compliance.

pen-source GxP-compliant predictive maintenance platform for U.S. pharmaceutical supply chain resilience. Aligned with Executive Order 14017. DOI: 10.5281/zenodo.19310968

FDA-Compliant Machine Learning Operations Pipeline — GMLP checklist automation, PCCP-ready model versioning, demographic bias monitoring, and drift detection

Free supplement ad creative frameworks, hook templates, and compliance checklists. By APXlab.

Global Life Sciences & Health Technologies Outlook (2026-2035) Strategic data frameworks and market intelligence analyzing the convergence of Biopharma, MedTech, and Healthcare Services. This repository hosts models and regulatory analysis focused on Integrated Resilience amidst geopolitical fragmentation, tracking the shift from volume based car