Nandini Murthy

Ms. Murthy is Principal and Founder of ENEM Consulting LLC, a regulatory consulting firm based in MA. As a Consultant with over 25 years of experience in industry, Ms. Murthy has worked with clients in industry and academia, on novel digital therapeutics, cardiovascular, gastroenterology devices and device-biologic and device-drug combination products.

Ms. Murthy has developed regulatory strategy, represented clients at FDA meetings and successfully authored FDA submissions for novel products, typically with no precedent regulatory pathway at the Agency. She has also led regulatory projects with inter-Center review, including neonatal device-biologic products, devices with GRAS components and drug delivery systems with mobile/digital applications. In addition to her core expertise in regulatory affairs, Ms. Murthy has designed and executed clinical trials and established quality systems to ISO and FDA Quality System requirements. This complementary work experience enables Ms. Murthy to provide the kind of comprehensive regulatory support crucial to novel, early-stage ventures, aligning the engineering and clinical support documentation with overall regulatory strategy.