Manage series 2821798
Por DSI, Meranda Parascandola, and Ed Narke descoberto pelo Player FM e nossa comunidade - Os direitos autorais são de propriedade do editor, não do Player FM, e o áudio é transmitido diretamente de seus servidores. Toque no botão Assinar para acompanhar as atualizações no Player FM, ou copie a feed URL em outros aplicativos de podcast.
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.