INSIGHTS ON REGULATORY COMPLIANCE

• The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

  In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

• The Future Of Compliance, Efficiency, And Data Integrity

  Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

• Overcoming Challenges In Ophthalmic Formulations

  Discover key strategies for overcoming formulation challenges in ophthalmic drug development and learn how selecting the right excipients supports quality, compliance, and safety.

• 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.

• Choosing The Right PCD Configuration For Reliable Sterility Assurance

  10/16/2025

  Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

• Prioritizing Data Security Through Digital Transformation

  5/2/2025

  Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

• Multispecific Antibodies: Key Challenges And Solutions To Enable A New Frontier In Cancer Treatment

  11/14/2025

  Multispecific antibodies are a newer class of cancer therapeutics addressing tumor complexity. Learn about the design, manufacturing, and regulatory challenges and integrated solutions accelerating their development.

• Innovations, Solutions, And USP <1062> With Scale Up

  11/4/2025

  Optimize tablet compression by simplifying calibration, speeding up changeovers, and utilizing advanced laser inspection to prevent critical punch tip wear and maintain quality.

• The Impact Of Artificial Intelligence On CQV

  7/23/2025

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.