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Axendia

Trusted Life-Science Advice

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FDA Is Using Modeling & Simulation. Why Aren’t You?

By Robyn Barnes, Marketing & Communications Manager / January 19, 2023 January 19, 2023

Axendia Analysis of “Successes and Opportunities in Modeling & Simulation for FDA” The last thing you want is to lag your regulator and in the …

FDA Is Using Modeling & Simulation. Why Aren’t You? Read More »

Simplifying the Complexities of Manufacturing

By Daniel R. Matlis, President & Founder / January 6, 2023 January 6, 2023

Rockwell Perspectives & Automation Fair 2022 Event Brief Rockwell’s Perspectives and Automation Fair 2022 provided an impressive showcase of the power and value of connecting …

Simplifying the Complexities of Manufacturing Read More »

Building the Industry Cloud for Life Sciences

By Sandra Rodriguez, Senior Industry Analyst / December 19, 2022 December 19, 2022

Event Brief: Veeva R&D and Quality Summit 2022 Axendia’s Sr. Industry Analyst, Sandra K. Rodriguez, attended Veeva Systems R&D and Quality Summit in Boston, MA. …

Building the Industry Cloud for Life Sciences Read More »

Do or Do Not… There is No Try in Digital Transformation

By Robyn Barnes, Marketing & Communications Manager / December 12, 2022 December 12, 2022

Digital CMC Summit Event Brief The 1st Annual Digital CMC Summit brought together more than 20 expert industry speakers presenting to an engaged audience representing …

Do or Do Not… There is No Try in Digital Transformation Read More »

Manufacturing Innovations To Overcome Dire Situations

By Jared Matlis, Research Assistant / December 8, 2022 December 8, 2022

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 »

Manufacturing at the Tempo of the Cloud

By Sandra Rodriguez, Senior Industry Analyst / October 27, 2022 October 28, 2022

Apprentice Briefing Note Axendia was recently briefed by the leadership team at Apprentice.  With 200+ employees and $142MM in venture funding, Apprentice has developed a …

Manufacturing at the Tempo of the Cloud Read More »

Entering a New Dimension with PAS-X

By Sandra Rodriguez, Senior Industry Analyst / October 26, 2022 October 26, 2022

Körber Business Area Pharma Connext Software Summit 2022 Event Brief Axendia’s Sr. Industry Analyst, Sandra K. Rodriguez, delivered the keynote address at Connext North America …

Entering a New Dimension with PAS-X Read More »

The Needle is Moving: Digital Transformation in Life-Sciences Manufacturing

By Axendia / September 14, 2022 September 15, 2022

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 »

FDA Releases New Draft Guidance on CSA

By Sandra Rodriguez, Senior Industry Analyst / September 13, 2022 September 20, 2022

Computer Software Assurance for Production and Quality System Software The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a …

FDA Releases New Draft Guidance on CSA Read More »

The Connected Workplace

By Sandra Rodriguez, Senior Industry Analyst / September 12, 2022 September 20, 2022

Nuvolo Briefing Note Axendia was recently briefed by Ethan Smith, General Manager, Life Sciences at Nuvolo, a cloud-based software company founded in 2014 and built …

The Connected Workplace Read More »

FDA Remote Regulatory Assessments Are Here To Stay

By Giselle Matlis, Research Assistant / September 7, 2022 September 8, 2022

FDA’s Proposed Guidance on Conducting Remote Regulatory Assessments Remote. Remote. Remote. Since the COVID-19 pandemic started in 2020, this is the word we now use …

FDA Remote Regulatory Assessments Are Here To Stay Read More »

FDA to Rate Industry on Quality Management Maturity

By Ellyn McMullin / August 1, 2022 September 13, 2022

The FDA is taking another step towards realizing the vision for pharmaceutical quality in the 21st century. To increase transparency and incentivize investment in mature …

FDA to Rate Industry on Quality Management Maturity Read More »

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