Published Articles
Ask the Expert: Complying with Standards
This Video was published by PharmTech. In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel,...
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Published Articles
Why Early FDA Engagement Is Make-or-Break for Medical Device Startups
By: Claire Wallace, Senior Writer, Informa Markets – Engineering. Published by Medical Device and Diagnostic Industry Many device startups think they're ready for FDA submission—until they discover they lack documented...
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Published Articles
Regulatory Actions Impacting Biologics
In this audio clip originally published by by PharmTech. Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished...
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Published Articles
Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56
In this episode of PharmTech’s Pharma Fundamentals, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates and a member of PharmTech's editorial advisory board, and Amnon Eylath, president and founder...
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Published Articles
Investigating Patient Complaints About Combination Products
In this audio clip originally published by by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies...
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Published Articles
Ask the Expert: Enhancing Out-of-Specification Procedures
This Video was published by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust...
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