Vol 82 – Strategies and Considerations for Effective CMC Submissions of Combination Products
Learn vital strategies for successful CMC submissions of combination products. Expert insights and key considerations explained concisely.
Vol 81 – Ensuring Data Integrity in CMC Submissions: Regulatory Expectations and Best Practices
Learn CMC submission data integrity best practices & meet regulatory expectations in this informative guide.
Vol 80 – Building a Framework for CMC Submissions: A Renewed Paradigm Shift in Pharmaceutical Development
Revolutionizing pharmaceutical development: Explore a new paradigm for CMC submissions framework in this insightful read.
Vol 79 – Strategies for Addressing Impurities in Biologic Drug Substance Manufacturing
Fight biologic drug impurities with prevention and real cases. Emphasizing vigilance, innovation, and collaboration for a safer future.
News 2023-08 EnkrisiGPT
Introducing EnkrisiGPT, Enkrisi’s 50-million parameter large language model, purpose-built from scratch for Regulatory Drug Development
Vol 78 – Addressing Extractables and Leachables in Drug Development: A Small Biotech Guide
This guide provides a concise overview for small biotech companies on managing Extractables and Leachables during drug development.
Vol 76 – Risk-Based Approaches to Cleaning Validation in CMC Drug Development
This approach optimizes cleaning validation processes in CMC drug development by prioritizing and addressing potential risks associated with drug product cross-contamination.
Vol 77 – Cracking the Code of Analytical Method Development and Validation in Biosimilars: Unmasking the Hidden Challenges
Unravel the complexities of analytical method development and validation in biosimilars as this enlightening publication exposes the concealed challenges.
Vol 73 – Developing a Phase-Appropriate CMC Development Plan for Small Biotechs
Creating a tailored CMC (Chemistry, Manufacturing, and Controls) development roadmap, suitable for the specific phase and needs of small biotechnology companies.
Vol 75 – Trends and Best Practices in Particle Size Analysis for Drug Products
This comprehensive report explores the latest trends and best practices in particle size analysis specifically tailored for drug products.