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 Advanced Manufacturing 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
Transforming Quality in the Cloud Read More »
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
FDA Shares a New Approach to CSV Read More »
