Risk Averted, Time Saved: How aiMDC Helped Prevent a Costly Drug Approval Delay | Case Study

The regulatory affairs team at a leading biopharmaceutical company was approaching a critical milestone: submitting a comprehensive approval package for a breakthrough oncology drug. With global regulatory deadlines looming and multiple agencies requiring nuanced variations of the documentation, the team faced an overwhelming challenge—reviewing and reconciling over 500 complex documents, including clinical trial data, adverse event reports, and local compliance forms, many exceeding 700 pages each.

The stakes were high. A single oversight in pharmacovigilance reporting or a missed inconsistency across documents could delay approval, trigger additional audits, or compromise trust with regulators. Traditional document review methods—manual reading, cross-checking, and siloed teams—were simply too slow, error-prone, and resource-intensive to keep pace with the volume and complexity. The company turned to aiMDC to accelerate and safeguard this process without compromising on precision.

aiMDC was able to simultaneously ingest and analyse thousands of pages across different formats and languages, including scanned PDFs and local regulatory texts. The platform’s ‘Show Highlights’ feature pinpointed exact pages and paragraphs containing high-risk data, automatically flagged inconsistencies, and generated executive-ready summaries for decision-makers. What previously took weeks of manual effort was now done in hours—accurately, confidently, and without missed context—transforming the team’s approach to regulatory compliance and helping secure a timely submission.