Biosimilar Regulatory solution center

1. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

2. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

   The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

3. How Does SUS Integrity Change Across Drug Product Lifecycle? 9/24/2026

   Learn how phase-appropriate risk justification, validation, documentation, and lifecycle controls can strengthen sterility assurance while reducing the potential for rework and delays.

4. Can Targeted LNP Delivery Take In-Vivo CAR-T Therapy Beyond The Liver? 9/17/2026

   Achieving successful extrahepatic CAR T delivery with LNPs requires addressing the unique biological and technological barriers and designing targeting approaches that leverage innovative LNP design.

5. Building Trust In AI For Computerized System Validation 9/4/2026

   Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

6. Controls For Retrieval-Augmented Generation In GxP 9/1/2026

   Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.

7. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

   When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

8. Chromatography Equipment Maintenance In An Era Of Acceleration 8/19/2026

   As chromatography systems become more sophisticated, maintenance directly influences uptime. Learn why coordinated maintenance strategies are essential for supporting complex analytical work.

9. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

   Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

10. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

    Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.