Agentic Enabled Query Resolution

Overview

Pharmaceutical, medical device, and life sciences companies regularly receive queries from Health Authorities / Regulatory Bodies (e.g., FDA, EMA, MHRA, BSI, NSAI). These queries typically seek clarifications, additional evidence, or corrective actions related to submissions, audits, or compliance reviews.

Business Problem:

• Health Authority queries are handled manually via email, spreadsheets, and shared folders
• Information is spread across multiple systems and documents
• Responses are time critical, with strict regulatory SLAs
• Lack of visibility leads to delays, missed deadlines, and compliance risks
• High dependency on subject matter experts, causing bottlenecks

Agentic Enabled Query Resolution is an Appian-based Automated query response framework designed to streamline how pharmaceutical, medical device, and life sciences organizations respond to regulatory queries issued by Health Authorities. The offering leverages Appian’s Agentic AI capabilities and Data Fabric to intelligently ingest, read, classify, and extract content from regulatory query documents received through email or other channels.

Key Features & Functionality

Key Components of the offering :-

• Query Ingestion & Document Processing
• AI-based Query Classification & Structuring
• Response Repository Search & AI Drafting
• Expert Assignment & Collaboration
• Review, Approval & Response Generation