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Building a Robust NDA/BLA Strategy: Ethan and Desi Discuss 5 Strategic Steps in Regulatory CMC for Approval
Manage episode 443346238 series 3603634
Treść dostarczona przez Despina & Ethan at Enkrisi and Ethan at Enkrisi. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Despina & Ethan at Enkrisi and Ethan at Enkrisi lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.
Welcome to "Accelerating the Path to Approval", hosted by Ethan and Despina from Enkrisi. In this podcast, we explore the critical steps in developing a robust Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy that can make or break a successful New Drug Application (NDA) or Biologics License Application (BLA) submission.
Today, we’ll be diving into the 5 Strategic Steps that ensure your CMC foundation is strong, well-structured, and aligned with regulatory expectations, significantly enhancing your chances of approval. From early regulatory engagement to continuous risk mitigation, we’ll walk you through real-world examples and case studies that illustrate the key elements in preparing a successful submission.
Ethan and Despina will also explore how early alignment with FDA and ICH guidelines, along with a transparent, data-driven approach, can streamline your approval process. Whether you're navigating the complexities of small molecules, biologics, or combination products, this podcast is your guide to mastering the regulatory landscape and accelerating your path to market.
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