The 500-Document Challenge: Winning Speed and Accuracy in Pharma Compliance
Risk Averted, Time Saved: How aiMDC Helped Prevent a Costly Drug Approval Delay | Case Study
Industry: Pharmaceuticals | Region: Global | Use Case: Traditional document review methods—manual reading, cross-checking, and siloed teams—were simply too slow
Your regulatory team is racing to submit approval documents for a breakthrough oncology drug. Deadlines are tight. Global agencies want tailored versions of over 500 complex documents—clinical trial results, safety data, and compliance forms—many over 700 pages. Reviewing everything by hand? Nearly impossible.
You can’t afford mistakes. One missed adverse event report or inconsistency could delay approvals, spark audits, or damage your credibility. Manual reviews are too slow and prone to human error. That’s why this biopharma team brought in aiMDC—an AI-powered document intelligence tool built for high-stakes reviews like yours.
aiMDC quickly read and compared thousands of pages across formats, languages, and even scanned PDFs. It highlighted risk-heavy sections, flagged inconsistencies, and created clear summaries for leadership. What once took weeks now took hours—with precision and confidence. The team hit their deadline and submitted a clean, compliant package—avoiding delays and securing regulator trust.
Client
Environment
Objective
To identify inconsistencies, omissions, and risks buried across 500+ complex technical documents—ensuring full regulatory compliance without the need for weeks of manual cross-referencing or human error.
What was done
aiMDC was deployed to process, interpret, and compare over 10,000 pages across multiple document sets. Using the ‘Show Highlights’ feature, teams instantly located discrepancies and missing pharmacovigilance data by pinpointing exact paragraphs and risk clusters. Multi-language OCR enabled analysis of translated reports and scanned medical records at speed.
Achievement
The team reduced regulatory review time by 80%, avoided a potential 6-month drug launch delay, and ensured full documentation traceability. aiMDC’s precision helped them respond to regulator questions faster, back with highlighted context, preventing a projected $35M revenue loss from launch deferral.
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
‘To protect client confidentiality, certain details have been modified; this case study is intended to illustrate the capabilities of aiMDC’
