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Case Study

MediSync: Automated FDA portal monitoring for 12 products

Automated FDA portal monitoring for 12 products

−85%
Manual monitoring time
0
Guidance updates missed
−60%
Audit preparation time

Company Background

MediSync builds clinical trial management software used by 200+ research institutions. Regulatory compliance is non-negotiable.

The Challenge

The regulatory affairs team was spending 10+ hours per week manually checking FDA, EMA, and MHRA portals for guidance updates affecting their 12 regulated products.

The Solution

MediSync deployed Monity with authenticated monitoring for restricted portals and plain-English AI prompts that understand regulatory language.

Implementation

Integrated with their compliance workflow via webhook. Each detected change automatically creates a task with the diff, source URL, and severity assessment.

"Our auditors were impressed by the complete change history Monity provides. It turned compliance from a burden into a competitive advantage."
Dr. Elena Vasquez
Regulatory Director, MediSync

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