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EY has announced the launch of EY Smart Reviewer, a technology-driven solution that leverages artificial intelligence (AI) and natural language processing to help accelerate and improve the process to review materials used to market pharmaceutical and medical device products.
”The industry's current Medical, Legal, Regulatory Review (MLR) process, which helps to ensure marketing materials comply with regulatory guidelines, is often slow, inconsistent and requires significant manual review times for documents. There are also significant risks if off-label or other non-compliant messaging are hastily approved. Non-compliance with regulations can result in millions of dollars in regulatory fines, as well as delay actively promoting essential new therapies in the market.
The EY Smart Reviewer solution “makes it possible for pharmaceutical and medical technology companies to automate the Medical, Legal, Regulatory Review (MLR) process and significantly shorten review and approval timelines for modular content, thus driving faster speed to market for essential medicines,” said EY in a press release. “It increases speed by eliminating key manual tasks and automating the remaining tasks and it reduces costs by freeing up high-value people to focus on higher value-adding omnichannel activities, while lowering risk of regulatory fines.” I
Twelve machine learning modules make up the solution, with new modules being developed and added over time. Currently available in English, EY Smart Reviewer will also be available in French, German, Spanish, Italian, Japanese and Chinese by early 2022.