INSIGHTS ON REGULATORY COMPLIANCE

• A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk

  Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

• Combination Products: Navigating Regulatory Strategy, Design Verification

  Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

• Why Biotech Leaders Can't Afford Delays In Document Review

  Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

• Stop Managing CQV In Silos: Unify Your Validation Systems

  Fragmented CQV systems hinder validation efforts, which risks compliance and slows progress. Discover how centralized platforms streamline processes, boost efficiency, and meet evolving regulatory demands.

• Digitalizing CQV

  7/1/2025

  Discover how digital C&Q streamlines processes, boosts compliance, and reduces risk, as well as learn how to align digital strategies with your goals for faster, smarter, and more efficient execution.

• Digital Transformation In Contract Manufacturing: A Leadership Perspective

  5/13/2025

  Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.

• Strategies For QA Professionals In Life Sciences

  7/14/2025

  Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

• Optimizing Aseptic Processing With Isolator Technology

  9/29/2025

  Discover how pharmaceutical isolators optimize operations, achieve higher sterility assurance, and meet stringent regulatory requirements. Learn about design principles, validation, and VHP cycles.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.