In this very special and spooky episode of CMC Live, Ed, Meranda and Brian host a happy hour and invite other members of the Design Space InPharmatics team to share the scariest stories from their careers. From walking through a morgue to gain access to medical records to a very noisy liquid oxygen tank, these stories will be sure to raise the hair on the back of your neck!

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

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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Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story