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Articles written by Mark D. Kramer, RAC

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage. ... Read more »

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Resorbable Polymer Implants: Remove Risk During Manufacturing, Sterilization and Packaging

This white paper seeks to identify critical considerations for Work-In-Process Exposure vulnerabilities of resorbable polymers. A disciplined assessment of the different contributors to the Overall Exposure Risk supports fact-based decisions to establish repeatable and capable manufacturing, packagi...

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