GMPilot: An Expert AI Agent For FDA cGMP Compliance

Large language models (LLMs) are increasingly used to generate domain-specific commercial & medical content (e.g., claims, statements, and promotional phrases) in regulated industries such as pharmaceuticals. However, ensuring its regulatory compliance, factual accuracy, and audience-specific personalization remains a major challenge. We report a production case study asking whether moving compliance and personalization signal from prompt-level rules into retrieval time structured context improves pharmaceutical claims generation, using Composer, a deployed internal tool built on a Golden Data Model (GDM) of 1,867 pharmaceutical claims spanning four products. The GDM integrates claim metadata, references, audience labels, material type, usage history, Match Text Variant (MTV) links, and a six dimension quality score (6C). Across six product-audience segments, the context pipeline improves intended indication (+29%), intended content type (+62%) and intended target audience (+67%), 6C quality score (+86%), and claim reuse (+34%). Production log analysis over the deployment period shows a 29.5% reduction in weekly API cost. We report this as descriptive deployment evidence. This work is a systems and data architecture contribution: it shows that in a regulated, high-stakes domain, restructuring claim data for retrieval-time filtering is a more scalable lever than expanding prompt-level rules, and documents the engineering path data cleaning, graph linking, and quality scoring.

Large Language Models (LLMs) are increasingly used for content creation in regulated domains such as pharmaceuticals, where content must be medical accurate and legally compliant. Traditional manual quality control (QC) is slow, error-prone, and create publication bottlenecks. To address this, we introduce a modular, LLM/VLMs-driven QC architecture, LRBTC (Language, Regulatory, Brand, Technical, Content Structure), implemented through a Student Teacher HITL architecture and Waterfall rule filtering logic for scalable, verifiable content validation. This architecture is designed to provide verifiable, traceable, and scalable content optimization. Our methods achieve 83.0% F1 and 97.5% recall on AIReg Bench, reducing missed violations five fold compared with Gemini 2.5 Pro. On CSpelling, it improves mean accuracy by +26.7 %. Our error analysis further reveals that while current models are strong at detecting misspellings (92.5% recall), they fail to identify complex grammatical (25.0% recall) and punctuation (41.7% recall) errors, highlighting a key area for future work. This work provides a practical, plug-and-play solution for reliable, transparent quality control of content in high-stakes, compliance-critical industries. We also provide demo access.

Tool-augmented large language model (LLM) agents promise to unify scientific reasoning with computation, yet their deployment in high-stakes domains like drug discovery is bottlenecked by two critical barriers: unconstrained tool-use governance and poor long-horizon reliability. In dependency-heavy pharmaceutical pipelines, autonomous agents often drift into irreproducible trajectories, where early-stage hallucinations multiplicatively compound into downstream failures. To overcome this, we present Mozi, a dual-layer architecture that bridges the flexibility of generative AI with the deterministic rigor of computational biology. Layer A (Control Plane) establishes a governed supervisor--worker hierarchy that enforces role-based tool isolation, limits execution to constrained action spaces, and drives reflection-based replanning. Layer B (Workflow Plane) operationalizes canonical drug discovery stages -- from Target Identification to Lead Optimization -- as stateful, composable skill graphs. This layer integrates strict data contracts and strategic human-in-the-loop (HITL) checkpoints to safeguard scientific validity at high-uncertainty decision boundaries. Operating on the design principle of ``free-form reasoning for safe tasks, structured execution for long-horizon pipelines,'' Mozi provides built-in robustness mechanisms and trace-level audibility to completely mitigate error accumulation. We evaluate Mozi on PharmaBench, a curated benchmark for biomedical agents, demonstrating superior orchestration accuracy over existing baselines. Furthermore, through end-to-end therapeutic case studies, we demonstrate Mozi's ability to navigate massive chemical spaces, enforce stringent toxicity filters, and generate highly competitive in silico candidates, effectively transforming the LLM from a fragile conversationalist into a reliable, governed co-scientist.