🎙️ New Podcast Drop: CMC Regulatory Strategies for Early Drug Development Success
Navigating the complexities of setting drug specifications with limited data is a challenge many pharmaceutical teams face, especially in the early stages of development.
Our latest episode of The VirtualPharm Podcast dives into this critical topic, offering a structured, risk-based approach to help you make informed decisions and stay aligned with regulatory expectations.
Small biotech teams, this one's for you! Our new 2-part podcast & blog series breaks down the essential steps to mastering CMC (Chemistry, Manufacturing, and Controls) compliance during early drug development.
🎙️ Part 1: From Phase 1 to Phase 2 We’re covering:
🔹 Why strategic CMC planning is a game-changer from the start
🔹 How early risk assessment can save you time (and money) later
🔹 The power of early engagement with regulatory authorities
But that’s just the beginning. Part 2 is coming this Winter, and it’s all about prepping for Phase 3 and the leap to commercialization.
Get ahead of the curve and position your drug for success. Listen now and see why CMC isn’t just a “checkbox” — it’s your competitive edge.
🎧 Listen on YouTube
🎧 Listen on Spotify
Curious? Click play and hear how to avoid costly mistakes and fast-track your journey to market! 💥
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Stay Tuned... Coming in January in Part 2
You’ve got a compound in development (or maybe you just in-licensed one) and secured funding. Now the real work begins. It’s a whirlwind of:
🔹 Sorting through what’s already been done (or not done)
🔹 Managing multiple contractors with different pieces of the project
🔹 Kicking off — or keeping alive — a drug development program.
All while trying to build a clear CMC development strategy and a regulatory plan that will pass muster with stakeholders and your Board of Directors. And of course, there’s the ever-present challenge of doing it all on a lean budget until key clinical milestones are hit.
So, what’s the move?
💡 What to prioritize now vs. later
💡 How to navigate "do vs. delay" decisions
💡 How to manage risks and get stakeholder support
💡 When (and how) to approach regulatory authorities with the best package possible
If you’re looking for answers to these questions, you’re not alone. The path forward isn’t always clear, but having a smart CMC strategy can be the difference between momentum and missed milestones.
Want to hear more on how to stay ahead of the curve? Catch the full discussion on our podcast!
Don’t let your first steps trip you up. Click play and learn how to stay on track, and stay in control. 💥