AI Document Answering
Using AI to streamline FDA Title 21 compliance and reduce review cycles
A mid-sized pharmaceutical and cosmetics company operating in both the U.S. and European markets sought to streamline their compliance and regulatory review processes, particularly around U.S. FDA Title 21 regulations. The company frequently needed to interpret and act on specific clauses from hundreds of pages of legal and regulatory documents. Manual review was slow, error-prone, and often required legal consultants.
The goal was to implement a solution that could answer specific compliance-related questions instantly by reading and understanding regulatory texts, reducing turnaround time for both internal reviews and external audits.
The company faced several critical pain points:
Slow Regulatory Review: Compliance officers and legal teams were spending hours searching for answers to specific questions across multiple sections of Title 21 and related documents.
Human Bottlenecks: High reliance on legal experts created backlogs during key product development phases, especially when launching new drug formulations or cosmetics with active ingredients.
Document Volume & Complexity: Title 21 consists of over 1,000 pages of complex language. Staff members lacked tools that could navigate, interpret, and cross-reference this content quickly.
Risk of Non-Compliance: Delays and errors in understanding key regulatory clauses introduced risk in decision-making processes, especially under strict FDA timelines.
To overcome these challenges, we deployed our AI-based Document Question Answering platform, designed specifically for regulatory and compliance-heavy environments. Here's how it helped:
Phase 1
Semantic Understanding of Title 21: Using a fine-tuned large language model (LLM), the system could understand and interpret complex legal language, surfacing relevant answers from across sections and subparts of Title 21.
Instant Q&A on Regulatory Documents: Compliance officers could ask natural language questions such as “What are the packaging requirements for topical drugs?” or “Do we need an IND for this formulation?”, and receive accurate, reference-backed answers with citations and context.
Phase 2
Structured Prompting with Context Windows: Our solution used a carefully engineered system prompt designed to guide the LLM to respond like a regulatory assistant, citing the exact clauses and avoiding hallucinations. Context from Title 21 sections was injected into the prompt in order to answer any questions on that section.
Cloud LLM API Integration: For each user query, relevant sections of FDA documentation were passed to a hosted, very large LLM via secure API calls. This allowed the system to deliver answers that balanced linguistic fluency with regulatory precision.
Phase 3
Private Cloud Setup: To ensure data confidentiality, the system was deployed in the client’s private infrastructure with document access controls.
API Integration with SharePoint: The platform was connected to the company's internal document management system to access internal SOPs, prior correspondence, and compliance notes.
The implementation of our Document Question Answering system transformed the client’s approach to regulatory review.
This project underscores our ability to apply cutting-edge AI to real-world regulatory challenges, unlocking new efficiencies for pharmaceutical and cosmetics companies navigating complex legal landscapes like FDA Title 21.
See it in action!
