INSIGHTS ON REGULATORY COMPLIANCE

• 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.

• Cell And Gene Therapy Innovations

  This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

• Uncovering Blind Spots In Environmental Monitoring

  Discover how modern strategies like the Contamination Control Strategy are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative microbial methods.

• How Compliance-Driven CDMOs Win Sponsor Contracts

  Discover how evolving global regulations are reshaping CDMO strategy. and how digital infrastructure helps manufacturers stay audit-ready, build sponsor trust, and turn compliance into an advantage.

• Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation

  9/17/2025

  Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

• Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing

  8/20/2024

  Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

• Calculating The ROI Of EAM/CMMS For Pharma Manufacturers And CDMOs

  10/6/2025

  Learn how modern EAM and CMMS systems help pharma manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.

• Ethylene Oxide For Industrial Sterilization: Part 1

  9/9/2025

  Understanding EO sterilization requires careful control of cycle variables and strict safety protocols. Learn how evolving standards and best practices ensure both effective sterilization and compliance.

• Comprehensive Regulatory Support

  8/29/2024

  Review our expertise across a wide range of global markets. Our experience in securing regulatory approvals and navigating market challenges positions us as a trusted partner.