Highlights of the Week?
- Navigating the New Regulatory Normal with Enkrisi Short – Narrated by Sir David Attenborough Here
- Playing Monopoly in Real Life – The Game of Regulatory CMC in Drug Development-Read our article on The Game of Regulatory CMC in Drug Development
Just ask Mr. Monopoly!?
- Introducing Our 7-Part Report: Navigating the Complexities of the Quality Module in CTD Submissions for Global Success. For more details and to obtain your copy of this indispensable report, please get in touch with us today. Listen to the Introduction Here
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Just in case you missed the Newsletter Last week…??
Read our article on Artist, Philosopher, and Regulatory Strategist Just ask Bruce Lee!
Read our article on Bringing Clarity to Your Regulatory Strategy
using Storyboarding. Just ask Alfred Hitchcock! ?
Blog Spotlight
Regulatory CMC Considerations -. Read All Past Articles Here
- ?Vol 3: Harness the Power of Augmented Intelligence for Streamlined Regulatory CMC Strategies in Drug Development Read the Full Article
- Vol 4: Unlocking The Guidelines For Designing Drug Substance & Product Stability Studies Read the Full Article
Enkrisi's Pathfinder Audiograms
Hot and On Time CMC Topics in Audio. Listen Now
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Key Guidance Interpretation?
- CMC Guidance Interpretation [The ICH Q9(R1) Guideline is a guideline on quality risk management for the pharmaceutical industry]. The guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. The guideline is intended to provide a systematic approach to quality risk management for better, more informed, and timely decisions Read More
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- Navigating CMC Information Amendments: A Quick Guide to Change Control, GMP Requirements, and FDA Enforcement Read More
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Featured Case Studies
Weekly Poll
Poll Question: What is Your Biggest Problem in Regulatory Drug Development?
- Navigating Complex Guidelines?
- Data and Analytical Challenges?
- Timely Effective Communication?
- Other...?
You can also vote and see how people vote here.?Learn more
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News Flash
- FDA - Releases Updated Draft Guidance for Formal Meetings on PDUFA Products Read More?
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- FDA - Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products – The purpose of this guidance is to provide FDA’s current thinking on 1) management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and 2) comparability studies to assess the effect of manufacturing changes on product quality. Read more
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- EMA - EMA releases new Q&A on biological products, covering several hot topics such as specifications for process impurities (including HCP), reprocessing, polysorbate control, etc? Read More
Upcoming Opportunities and Events
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. Our AI-powered solution ensures legal compliance by leveraging data, analytics, and machine learning. Say goodbye to manual burdens, optimize resource allocation, and stay ahead of regulations. Experience the future of regulatory compliance with EnkrisiGPT's advanced technology.
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