🎙️ CMC.live

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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August 7, 2020

Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda, Brian and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.
July 31, 2020

Expedited Drug Development with James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.
July 27, 2020
CMC Live

Introduction to CMC Live

Welcome to CMC Live. This is the show where the DSInPharmatics team 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.