Accelerating Regulatory Compliance with AI-Powered Documentation and FDA Code Prediction

A specialized regulatory consulting firm serving MedTech, Biologics, and SaMD/Combination Product companies. They provide end-to-end support for FDA and global compliance, guiding organizations from early-stage development through to final product approvals.

The Need:
The client sought to digitize and scale their consulting operations by creating an intelligent platform capable of automating regulatory documentation, resolving queries in real time, and offering predictive insights. A critical requirement was maintaining compliance with strict ISO and FDA standards while accelerating classification and submission processes.

Our Solution:
We leveraged Azure OpenAI services to develop a domain-specific chatbot for real-time interaction with regulatory documents. Additionally, we engineered a custom AI algorithm to predict FDA product codes accurately—streamlining classification tasks. Key to our solution was an automated data extraction pipeline integrated with a vector database to support semantic search and improve document accessibility.

Outcome Achieved:

• Deployed an intelligent chatbot capable of handling complex regulatory queries in real time
• Built a robust FDA code prediction engine that improved classification accuracy and speed
• Implemented an automated information extraction pipeline for unstructured documents
• Integrated a semantic vector database for efficient document search and retrieval
• Enhanced operational efficiency and user experience while maintaining full compliance standards