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
Vol 31: A Strong Foundation: Best Practices for Developing a CMC Strategy for Your Drug Product
A Strong Foundation: Best Practices for Developing a CMC Strategy for Your Drug Product
Vol 30: Tailoring for Clinical Phase Appropriate: Why One Size Does Not Fit All in Regulatory Drug Development
Tailoring for Clinical Phase Appropriate: Why One Size Does Not Fit All in Regulatory Drug Development
Vol 29: How Data Analysis Can Improve Regulatory Compliance
How Data Analysis Can Improve Regulatory Compliance
Vol 28: Presenting CMC Data in an NDA/BLA: A Strategic Approach for Successful Regulatory Submissions
Presenting CMC Data in an NDA/BLA: A Strategic Approach for Successful Regulatory Submissions
Vol 27: Reimagining Drug Development: How Augmented Intelligence combined with Human Expertise are Transforming CMC Regulatory Submissions
Reimagining Drug Development: How Augmented Intelligence combined with Human Expertise are Transforming CMC Regulatory Submissions
Vol 26: Mastering the Art of CMC Communication: A Quick Guide to Crafting a Winning NDA Submission
Mastering the Art of CMC Communication: A Quick Guide to Crafting a Winning NDA Submission