Nothing Left to Interpretation: How AI Prevented a Safety Filing Disaster
Every Word Counted: Inside the AI System That Turned 7,500 Pages Into a Submission Regulators Trusted | Case Study
There was no room for error. A global pharmaceutical company was preparing a critical set of safety documentation for submission to regulators in three regions. The pressure was high—any inconsistency between clinical summaries, technical documentation, and safety reporting could delay product approval, or worse, trigger compliance investigations.
Unlike previous cycles burdened by human cross-checking and siloed workflows, this time they used aiMDC. The AI read thousands of pages across multiple formats—clinical reports, safety data sheets, internal reviews—and returned insights that were not just fast, but verifiable. Every statement, every risk factor flagged, came with a link back to its original source — highlighted and timestamped.
With regulatory deadlines looming, the team used aiMDC’s “Show Highlights” feature to prepare bulletproof summaries and traceable assessments. Unlike generic AI tools that hallucinate or paraphrase inaccurately, aiMDC anchored every output to document reality. That made the difference between a last-minute scramble and confident, clean submission.
Client
Environment
Objective
To ensure zero-error, source-verified safety documentation for multi-region regulatory compliance, avoiding submission delays or audit risk
What was done
aiMDC was deployed to analyse 7,500+ pages across safety documents, clinical trial appendices, and compliance logs. The “Show Highlights” feature traced every AI-generated insight directly to the originating paragraph or section. Risk flags, inconsistencies, and summaries were surfaced, verified, and reviewed by the internal QA team within days, not weeks
Achievement
The pharma firm submitted a fully traceable, audit-ready safety package on schedule — avoiding what could have been a months-long delay and reputational damage. Regulators requested fewer clarifications than in prior submissions, attributing clarity and document traceability as key factors. By eliminating hallucinated or unsupported summaries, aiMDC helped the team avoid regulatory penalties and rework that could have cost millions in lost launch time. Just as crucially, it built internal confidence around AI—a tool they now trust with their most sensitive documentation.
What happens next…
Take control of your document challenges today. Connect with our experts, see aiMDC in action, and discover how precision AI can transform your workflow—saving you time, reducing risks, and boosting results. Ready to lead with confidence? Get started with aiMDC
