CMC Live - Chemistry, Manufacturing & Controls

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Manage series 2821798
著作 DSI, Meranda Parascandola, and Ed Narke の情報はPlayer FM及びコミュニティによって発見されました。著作権は出版社によって所持されます。そして、番組のオーディオは、その出版社のサーバから直接にストリーミングされます。Player FMで購読ボタンをタップし、更新できて、または他のポッドキャストアプリにフィードのURLを貼り付けます。
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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