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A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval
Manage episode 443021820 series 3603634
Контент предоставлен Despina & Ethan at Enkrisi and Ethan at Enkrisi. Весь контент подкастов, включая эпизоды, графику и описания подкастов, загружается и предоставляется непосредственно компанией Despina & Ethan at Enkrisi and Ethan at Enkrisi или ее партнером по платформе подкастов. Если вы считаете, что кто-то использует вашу работу, защищенную авторским правом, без вашего разрешения, вы можете выполнить процедуру, описанную здесь https://ru.player.fm/legal.
In this insightful episode, hosts Ethan and Desi take you on a deep dive into the drug approval process, emphasizing the critical role of Chemistry, Manufacturing, and Controls (CMC) documentation. With a focus on what sponsors often miss, the discussion highlights how inadequate preparation in key areas like stability studies, process validation, and facility readiness can lead to costly delays or rejections. The episode is packed with actionable advice on how to streamline the submission process, collaborate effectively with Contract Manufacturing Organizations (CMOs), and ensure regulatory compliance to expedite drug approval. Whether you're navigating the NDA or BLA submission process, this episode provides a strategic roadmap to success in drug approvals.
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