INSIGHTS ON REGULATORY COMPLIANCE

• How To Do Quick, Easy Cleanroom Classification

  Classification plays a vital role in cleanroom certification and qualification. Discover a particle counter that simplifies testing for adherence to ISO 14644-1, EU GMP Annex 1, or China GMP standards.

• Leveraging Tech, Regulatory Frameworks To Deliver Patient Access Today

  Amidst the shift toward decentralized manufacturing models, consider an approach that allows for standardized processes, remote monitoring and control, and centralized quality oversight.

• How Non-Destructive Headspace Analysis Advances CCI Testing

  Opting to use headspace analysis to assess container closure integrity (CCI) for your drug packaging ensures robust data and CCI assurance to protect your product and maintain regulatory compliance.

• EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging

  Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

• 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 Shift To GMP-Compliant Automation In CGT Manufacturing

  10/6/2025

  Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.

• Tips For Tracking And Recreating Your Golden Batch

  9/18/2025

  Discover how pharmaceutical manufacturers are using digital tools to achieve the “golden batch”—a production run that balances quality, efficiency, and compliance through smarter processes.

• The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

  3/3/2025

  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.

• Join Us At Summit CXO

  8/14/2025

  Join top life sciences executives at Summit CXO, October 6–8 in Salt Lake City, for exclusive insights, expert speakers, and powerful networking that will elevate your leadership and strategic impact.