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The U.S. client is the manufacturer of IVDs and blood products. The client had created labeling in compliance with the US FDA labeling regulations for a new product.

Business Challenge
The internal team at the company had conflicting views on whether or not the labeling documents, consisting of almost 60 images complied with the latest FDA’s labeling requirements. The team had spent months discussing the matter internally with no consensus.

The Senior Director of Regulatory Affairs wanted to obtain clarity on the labeling before the FDA submission. RegDesk compiled a flash team of three experienced FDA labeling experts to review the labeling. These experts on average had 20 years of regulatory experience specifically with IVD products. The experts provided feedback and identified claims that would raise questions with the FDA.

The Senior Director obtained multiple viewpoints on the labeling within 3 weeks. The internal review process of the labeling was a vain attempt and had wasted several months. The client leveraged the insights received through RegDesk to modify the claims appropriately and forecast FDA’s response.

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at or visit