Blogs
The “Hard Part” of Combination Products: Design Controls
Why Design Controls Are the Biggest Leap for Drug Teams For pharmaceutical and biologic organizations entering the combination product space, few regulatory requirements cause as much friction as design controls...
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Published Articles
Ask the Expert: Working with Regulators to Develop Orphan Drugs
In this episode of the Ask the Expert video series hosted by Pharmaceutical Technology®, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development...
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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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