Vol 40: Best Practices for Setting Analytical Method Specifications
Optimizing Analytical Method Performance through Thoughtful Specification Setting
Vol 39: The Role of API Process Development in CMC Drug Development: A Comprehensive Overview
Optimizing the Drug Development Process: The Critical Importance of API Process Development
Vol 38: Get it Right the First Time: The Key to a Successful Regulatory Filing with Source Document Management and CTD Quality Module 3 Syncing
Streamlining Regulatory Compliance: Best Practices for Source Document Management and CTD Quality Module 3 Coordination
Vol 37: Unleash the Power of QbD: Transform Your Drug Product Development and Ensure Quality, Reliability, and Regulatory Approval
Revolutionizing Drug Product Development with Quality by Design (QbD) Principles
Vol 36: From Start to Finish: Managing Impurities and Degradants Throughout Drug Product Development
Controlling Impurities for Safe and Effective Drug Product Development
News 2023-04 Enkrisi Launch
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Vol 35: The Proof is in the Pudding: How Analytical Methods Development and Validation are Crucial for Successful Drug Development!
From Bench to Bedside: The Role of Rigorous Analytical Method Validation in Drug Development
Vol 34: The Test of Time: Understanding the Importance of Stability Testing for Your Drug Product
Ensuring the Safety and Efficacy of Pharmaceuticals through Comprehensive Stability Testing
Vol 33: A Quick Scaling Up Guide – A Robust Drug Product Manufacturing Process that Meets Regulatory Requirements
Streamlining Production for Efficient and Compliant Drug Manufacturing
Vol 32: Ensuring Regulatory Compliance: Key Considerations for Developing a “Robust” Drug Substance Manufacturing Process
Ensuring Regulatory Compliance: Key Considerations for Developing a “Robust” Drug Substance Manufacturing Process