FDA’s Position Paper on Distributed Manufacturing and Point-of-Care Manufacturing Throughout literature and movies, there is a trope that sufficient strife will produce sufficient innovations to …
Manufacturing Innovations To Overcome Dire Situations Read More »
Research Report This report highlights how life-sciences companies are reimagining the way they operate by leveraging advanced manufacturing technologies. We think you’ll find the results …
The Needle is Moving: Digital Transformation in Life-Sciences Manufacturing Read More »
Debunking Industry Myths on Regulatory Science For FDA, Advanced Manufacturing means an approach for the manufacturing of pharmaceutical, biologics, and devices that incorporates novel technology, …
FDA is Encouraging Advanced Manufacturing – Are YOU Ready? Read More »
Emerson Briefing Note Axendia was recently briefed by, Kristel Biehler, Vice President Life Sciences at Emerson on the company’s acquisition of Fluxa to strengthen its …
Managing the Digital Recipe Development Lifecycle Read More »
Debunking Industry Myths on Regulatory Science FDA is moving Regulatory Science into the 21st century. To this end, the Agency is driving innovation of tools, …
FDA is Moving Regulatory Science into the 21st Century, Are You Ready? Read More »
An Axendia Insight Brief The demand for organizational visibility, control, and collaboration to achieve resilience during unprecedented times is a catalyst to digital transformation in …
Q&A from an Axendia Straight from the Source (SftS) Webinar By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President In our recent webinar, we …
FDA Answers Your Questions on the New Approach to CSV Read More »
A Straight from the Source Webinar The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to …
