Ten CMC Questions for Emerging Biotechs in 2025
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Ten CMC Questions for Emerging Biotechs in 2025
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This podcast presents ten crucial questions for emerging biotech companies to consider when reviewing their Chemistry, Manufacturing, and Controls (CMC) strategies at year-end. The questions cover various aspects, including regulatory milestones, data analytics, risk management, quality assurance, and future goals. Each question includes examples illustrating its importance for successful drug development. The ultimate aim is to ensure a robust CMC strategy aligned with regulatory expectations and industry best practices, thereby minimizing delays and maximizing the chances of successful submissions. Failing to address these questions could result in significant setbacks.
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