Welcome to CMC Live. This is the show where we discuss CMC regulations and guidances simplified through real life experiences and risk-based advice. Each episode we speak with Subject Matter Experts as well as other leading industry authorities. In this episode trailer, Ed Narke, Meranda Parascandola and Brian Lihou introduce the podcast and explain what listeners can expect in future episodes.

Welcome to CMC Live!

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.

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Welcome to CMC Live!

Welcome to CMC Live!