How Storyboarding Can Bring Clarity to Regulatory CMC Strategy and Execution

Sept 19, 2023

• 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

• Regulatory CMC Considerations: Developing Modified Versions of Immediate Release Oral Solid Dosage Forms. Read the Full Article ?
• Navigating the Storm: A Guide to Managing and Reporting Quality-Related Issues, Adverse Events, Product Complaints, and Product Recalls. Read the Full Article ??

News Flash

• Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement. Read More .?
• Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program - FDA will begin accepting requests to participate in year two of the CDRP on October 2, 2023.?? Sponsors in the pilot can discuss CMC strategies with FDA staff during two Type B meetings. They can have follow-up talks for further clarification. This enhances communication, aiding in CMC completion for faster drug development and earlier patient access. Learn more here ?

Enkrisi's Pathfinder Audiograms!

Hot and On Time CMC Topics in Audio. Listen Now ?

• Writing a Robust Stability Protocol for CMC Submissions
• Implications of Recent Regulatory Changes on CMC Drug Development: A Look Ahead ?

Key Guidance Interpretation?

• CMC Guidance Interpretation [Comparability Protocols for Post approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA; Guidance for Industry]: Read More ?
• ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances - Scientific guideline. A comprehensive look at the guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin and new drug products produced from them. Read more here ?

Featured Case Studies

• MANUFACTURING SCALE-UP PROBLEMS IN A BIOLOGIC FOR A NEUROLOGICAL DISORDER Download Case Study

Weekly Poll

Navigating CMC Strategy for Orphan Drugs: Given the Orphan status, what are the Key CMC Considerations?nbsp;

• Formulation and Stability for Rare Diseases?
• Process Development, Scalability, and Cost?
• Regulatory Compliance with Incentives?
• Risk Management with Limited Data

You can see how people vote.?Learn 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.

Stay Connected

• Follow us on LinkedIn ?for real-time updates.?
• Visit our Website: FIRST-EVER HYBRID MODEL CONSULTANCY ?
• Contact us: [email protected] ?

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.

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