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Published Articles



Our experts are featured in industry-leading publications and provide deep insights into the science behind our services.



November 5, 2025

USP 1119 and 1119.1: The Future of Risk-Based Bioburden Testing Standards

Published In: Contract Pharma

Through this conversation, Christine Walton helps clarify the intent and application of USP <1119> and <1119.1>, positioning them not as...

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June 19, 2025

Laying the Foundation: Integrating Risk and Culture into Quality Systems

Published In: Pharm Tech Outlook

Through this article, Tiffany Anderson reframes quality not as a bureaucratic obligation, but as a strategic enabler of safety, trust,...

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June 6, 2025

Guidance on Quality Culture Standards

Published In: Pharmaceutical Technology and BioPharm International

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a...

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May 28, 2025

3D Printing Considerations for Regulatory Acceptance

Published In: Orthopedic Design & Technology (ODT)

In this article Bryce Telford and Logan Luke discuss the unique considerations, such as sterilization and packaging, to chart a...

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January 8, 2025

Modern Microbial Methods Supporting a Contamination Control Strategy

Published In: Parenteral Drug Association (PDA)

This article discusses how modern microbial methods (also known as rapid microbiological methods or alternative methods) can support a contamination...

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