Vivera welcomes Mr. Dennis Moore as its Regulatory and Compliance Advisor. Mr. Moore will guide Vivera through the regulatory pathway for ZICOH, the Company’s intelligent, dose-controlled prescription medication delivery system.
Mr. Moore is a former United States Food and Drug Administration (FDA) Investigator and California Medical Device Senior Investigator with more than twenty years of experience. He has assisted many medical device and drug firms in achieving FDA compliance and has led his own biotechnology company as CEO for over a decade. His expertise will be particularly instrumental as Vivera moves through the regulatory process, ensuring ZICOH is safe and effective.
“I am eager to help Vivera achieve its goals in a fast, efficient, and soundly scientific manner,” said Mr. Moore. “I bring many years of FDA expertise and industry savvy to my role. I am focused on bringing the ZICOH Remote Medication Management System device to life with a goal to help patients achieve sound and successful therapy endpoints.”
“Vivera’s primary objective with ZICOH is to improve prescription medication safety and compliance by connecting the drug supply chain,” said Paul Edalat, Chairman, CEO, and Founder of Vivera. “As a former FDA Investigator, Mr. Moore knows the ins and outs of the FDA regulatory process. We look forward to working with him and his team to ensure ZICOH is FDA-compliant.”
Mr. Moore is a Sworn Government-POST Certified Criminal Investigator and Lead Trainer and a member of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of those involved with regulating healthcare and related products, including medical devices and pharmaceuticals. He also belongs to the Association for the Advancement of Medical Instruments (AAMI), a nonprofit organization that aims to advance the development, safety, and efficacy of medical technology.
Source: Vivera
