Come dive into one of the curiously delightful conversations overheard at National Geographic’s headquarters, as we follow explorers, photographers, and scientists to the edges of our big, weird, beautiful world. Hosted by Peter Gwin and Amy Briggs.
…
continue reading
Content provided by DSI, Meranda Parascandola, and Ed Narke. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by DSI, Meranda Parascandola, and Ed Narke or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
Player FM - Podcast App
Go offline with the Player FM app!
Go offline with the Player FM app!
CMC Live - Chemistry, Manufacturing & Controls
Mark all (un)played …
Series home•Feed
Manage series 2821798
Content provided by DSI, Meranda Parascandola, and Ed Narke. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by DSI, Meranda Parascandola, and Ed Narke or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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.
…
continue reading
27 episodes
Mark all (un)played …
Series home•Feed
Manage series 2821798
Content provided by DSI, Meranda Parascandola, and Ed Narke. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by DSI, Meranda Parascandola, and Ed Narke or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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.
…
continue reading
27 episodes
All episodes
×Welcome to Player FM!
Player FM is scanning the web for high-quality podcasts for you to enjoy right now. It's the best podcast app and works on Android, iPhone, and the web. Signup to sync subscriptions across devices.