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Since 2016, Nilo Medical Consulting Group, LLC has partnered with medical device, pharmaceutical, and biotechnology companies to deliver regulatory consulting and clinical research services. They support innovators across the product lifecycle—from concept development to global market entry—with services including clinical trial design and execution, regulatory submissions and agency interactions, product development and quality systems, CRO services including monitoring and data management, and reimbursement strategy. They offer flexible engagement options, including full-service CRO support or à la carte consulting, and they prepare 510(k), De Novo, PMA, IDE, and global submissions while pursuing FDA interactions and designations such as Breakthrough Device and STeP.
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