![The VirtualPharm Artwork](https://www.buzzsprout.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaHBCTHhSMlFjPSIsImV4cCI6bnVsbCwicHVyIjoiYmxvYl9pZCJ9fQ==--d67795123812fb997fb04fef1c98bf73a47e8500/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaDdDVG9MWm05eWJXRjBPZ2hxY0djNkUzSmxjMmw2WlY5MGIxOW1hV3hzV3docEFsZ0NhUUpZQW5zR09nbGpjbTl3T2d0alpXNTBjbVU2Q25OaGRtVnlld1k2REhGMVlXeHBkSGxwUVRvUVkyOXNiM1Z5YzNCaFkyVkpJZ2x6Y21kaUJqb0dSVlE9IiwiZXhwIjpudWxsLCJwdXIiOiJ2YXJpYXRpb24ifX0=--1924d851274c06c8fa0acdfeffb43489fc4a7fcc/1.png)
The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
Podcasting since 2024 • 24 episodes
The VirtualPharm
Latest Episodes
Ten CMC Questions for Emerging Biotechs in 2025
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 milestone...
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23:05
![The VirtualPharm Artwork](https://www.buzzsprout.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaHBCTHhSMlFjPSIsImV4cCI6bnVsbCwicHVyIjoiYmxvYl9pZCJ9fQ==--d67795123812fb997fb04fef1c98bf73a47e8500/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaDdDVG9MWm05eWJXRjBPZ2hxY0djNkUzSmxjMmw2WlY5MGIxOW1hV3hzV3docEFmcHBBZnA3QmpvSlkzSnZjRG9MWTJWdWRISmxPZ3B6WVhabGNuc0dPZ3h4ZFdGc2FYUjVhVUU2RUdOdmJHOTFjbk53WVdObFNTSUpjM0puWWdZNkJrVlUiLCJleHAiOm51bGwsInB1ciI6InZhcmlhdGlvbiJ9fQ==--bfdad5b04912fa8a9db85eb3989e46c5908e2723/1.png)
CMC Regulatory for Early Drug Development Success
Cracking the Code CMC Regulatory Compliance in Early Drug Development Summary This two-part blog post and podcast series provides a guide for small biotech companies on navigating Chemistry, Man...
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Season 1
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Episode 23
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21:15
![The VirtualPharm Artwork](https://www.buzzsprout.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaHBCTHhSMlFjPSIsImV4cCI6bnVsbCwicHVyIjoiYmxvYl9pZCJ9fQ==--d67795123812fb997fb04fef1c98bf73a47e8500/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaDdDVG9MWm05eWJXRjBPZ2hxY0djNkUzSmxjMmw2WlY5MGIxOW1hV3hzV3docEFmcHBBZnA3QmpvSlkzSnZjRG9MWTJWdWRISmxPZ3B6WVhabGNuc0dPZ3h4ZFdGc2FYUjVhVUU2RUdOdmJHOTFjbk53WVdObFNTSUpjM0puWWdZNkJrVlUiLCJleHAiOm51bGwsInB1ciI6InZhcmlhdGlvbiJ9fQ==--bfdad5b04912fa8a9db85eb3989e46c5908e2723/1.png)
Setting Drug Specifications in Data-Limited Scenarios
This Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. T...
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Season 1
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Episode 22
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20:44
![The VirtualPharm Artwork](https://www.buzzsprout.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaHBCTHhSMlFjPSIsImV4cCI6bnVsbCwicHVyIjoiYmxvYl9pZCJ9fQ==--d67795123812fb997fb04fef1c98bf73a47e8500/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaDdDVG9MWm05eWJXRjBPZ2hxY0djNkUzSmxjMmw2WlY5MGIxOW1hV3hzV3docEFmcHBBZnA3QmpvSlkzSnZjRG9MWTJWdWRISmxPZ3B6WVhabGNuc0dPZ3h4ZFdGc2FYUjVhVUU2RUdOdmJHOTFjbk53WVdObFNTSUpjM0puWWdZNkJrVlUiLCJleHAiOm51bGwsInB1ciI6InZhcmlhdGlvbiJ9fQ==--bfdad5b04912fa8a9db85eb3989e46c5908e2723/1.png)
Mastering CMC Quality Module 3 & QOS for NDA Submissions
This guide explains how to create a high-quality CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the FDA. It emphasizes the importance of these documents for regulatory compliance, accele...
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Season 1
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Episode 21
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20:03
![The VirtualPharm Artwork](https://www.buzzsprout.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaHBCTHhSMlFjPSIsImV4cCI6bnVsbCwicHVyIjoiYmxvYl9pZCJ9fQ==--d67795123812fb997fb04fef1c98bf73a47e8500/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaDdDVG9MWm05eWJXRjBPZ2hxY0djNkUzSmxjMmw2WlY5MGIxOW1hV3hzV3docEFmcHBBZnA3QmpvSlkzSnZjRG9MWTJWdWRISmxPZ3B6WVhabGNuc0dPZ3h4ZFdGc2FYUjVhVUU2RUdOdmJHOTFjbk53WVdObFNTSUpjM0puWWdZNkJrVlUiLCJleHAiOm51bGwsInB1ciI6InZhcmlhdGlvbiJ9fQ==--bfdad5b04912fa8a9db85eb3989e46c5908e2723/1.png)
Playing Monopoly in Real Life – The Game of Regulatory CMC in Drug Development
The podcast explains the complexities of the Regulatory Chemistry, Manufacturing, and Controls (CMC) process in drug development by drawing an analogy to the popular board game Monopoly. The author compares various aspects of the CMC pro...
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Season 1
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Episode 20
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15:25
![The VirtualPharm Artwork](https://www.buzzsprout.com/rails/active_storage/representations/redirect/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaHBCTHhSMlFjPSIsImV4cCI6bnVsbCwicHVyIjoiYmxvYl9pZCJ9fQ==--d67795123812fb997fb04fef1c98bf73a47e8500/eyJfcmFpbHMiOnsibWVzc2FnZSI6IkJBaDdDVG9MWm05eWJXRjBPZ2hxY0djNkUzSmxjMmw2WlY5MGIxOW1hV3hzV3docEFmcHBBZnA3QmpvSlkzSnZjRG9MWTJWdWRISmxPZ3B6WVhabGNuc0dPZ3h4ZFdGc2FYUjVhVUU2RUdOdmJHOTFjbk53WVdObFNTSUpjM0puWWdZNkJrVlUiLCJleHAiOm51bGwsInB1ciI6InZhcmlhdGlvbiJ9fQ==--bfdad5b04912fa8a9db85eb3989e46c5908e2723/1.png)