James P Stumpff

James P. Stumpff, RPh, is principal consultant with Parexel International, jim.stumpff@parexel.com.

Articles

March 15th 2022

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

Succeeding With OOS and Root-Cause Investigations

James P Stumpff

July 1st 2020

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Latest Updated Articles

Published: October 11th 2024 | Updated: October 18th 2024

Buy, Sell, Hold: Cell and Gene Therapy - Part 1

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

Published: September 10th 2024 | Updated: September 18th 2024

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Published: February 23rd 2024 | Updated: December 21st 2024

Europa Perspectives: Helping to Navigate the Regulatory System

Published: December 13th 2024 | Updated: December 21st 2024

FDA Creates CDER Center for Real-World Evidence Innovation

Close-up of a microscope lens examining microarray slides, a crucial tool in genomic research and medical diagnostics | Image Credit: © Varunee - Stock.Adobe.com

Published: December 5th 2024 | Updated: December 21st 2024

Leveraging Advancements in Bioanalytical Testing

Lipid nanoparticle siRNA antiviral delivery system, 3D illustration | Image Credit: © Dr_Microbe - © Dr_Microbe - stock.adobe.com

Published: December 7th 2024 | Updated: December 21st 2024

Exploring Opportunities for LNP Delivery in mRNA

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