An Artist, Philosopher, and Regulatory Strategist? Just ask Bruce Lee! Read it here
And... Just in case you missed the Newsletter Last week…?Read our article on Bringing Clarity to Your Regulatory Strategy using Storyboarding. Just ask Alfred Hitchcock! ? Request an?editable storyboard template?(Word format) for your Regulatory CMC Strategy?here?and put it to use in your organization.?
Blog Spotlight
- 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
- The Pathfinder Newsletter: The PathFinder is a Regulatory intelligence newsletter publication that provides Lifesciences organizations with up-to-date information on current and upcoming regulations. Read Past Articles Here?
Enkrisi's Pathfinder Audiograms
Hot and On Time CMC Topics in Audio. Listen Now?
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?
- CMC Guidance Interpretation [Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products] - The draft guidance aims to clarify the FDA's stance on manufacturing changes and comparability assessments for human CGT products. Open for Public Comment - The document is in draft form, meaning it is open for public comment. Industry stakeholders have the opportunity to provide feedback before it becomes finalized. Read more here?
Featured Case Studies
Weekly Poll
Poll Question: What is your most pressing CMC regulatory question concerning Post-Approval Supplements??
- Change in Manufacturing Site?
- Modification in Formulation?
- Analytical Method Changes?
- Something Else??
You can see how people vote.?Learn more?
News Flash
- FDA - Releases Updated Draft Guidance for Formal Meetings on PDUFA Products Read More???
- 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?
- 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
- Introducing EnkrisiGPT - Automate regulatory checks with EnkrisiGPT. 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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Enkrisi provides a capable and dynamic consultancy that stands out from the rest regarding drug development and regulatory affairs within the pharmaceutical industry. Through leveraging data, apps, and platforms with Augmented Intelligence (IA), Enkrisi offers clients an impressive experience backed by experienced human advisors. With their expertise, you can ensure your drugs are optimized for success and make an impact in the life sciences universe.
Chief Commercial Officer, BirdoTech
1 年Hi Ed, great writing! Do you have time to briefly chat now?