• A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval

  • Oct 1 2024
  • Length: 10 mins
  • Podcast

A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval

Listen for free

View show details

  • Summary

  • 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.

    Support the show
    Show more Show less
activate_Holiday_promo_in_buybox_DT_T2
Show more Show less

What listeners say about A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval

Average customer ratings

Reviews - Please select the tabs below to change the source of reviews.

Audible.com reviews

Amazon reviews
No Reviews are Available