White Papers
Expanding Your Pharmaceutical QMS for Combination Product Success
Pharmaceutical and biologics companies are rapidly moving into prefilled syringes, autoinjectors, on body injectors, and connected delivery systems, but most discover too late that their traditional drug based QMS cannot...
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Case Studies
Accelerated Facility Expansion for High-Value Drug Product
Background A pharmaceutical manufacturer faced a significant capacity shortfall for a high-value drug product, with demand forecasts projecting accelerated growth. The expansion carried a high-risk profile due to complex interdependencies...
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Blogs
FDA’s New QMSR Final Rule: What Medical Device Manufacturers Need to Know (2026)
The FDA’s Quality Management System Regulation (QMSR) replaces the legacy QSR and formally incorporates ISO 13485:2016 (and ISO 9000:2015 Clause 3 for terminology) by reference. The final rule was issued...
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Webinars
End-to-End Human Factors for Medical Devices and Re-processing Usability Testing
Human Factors Engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and effective in real-world use. Join Regulatory Compliance Associates (RCA) and Nelson Labs for...
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Published Articles
Ensuring the Supply Chain through Purchasing Controls
Building a Secure and Resilient Pharmaceutical Supply Chain In this article, Jane Zhang, Co-Founder and Co-CEO of ETCH Sourcing, and Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson...
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Published Articles
Fundamentals of Batch Recovery Procedures
Pharmaceutical Batch Recovery Procedures In this article, Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, discusses best practices for recovering pharmaceutical manufacturing batches following production deviations....
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