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 »
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 …
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. …
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 »
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 »
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 …
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 …
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 »
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 …
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 …
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 »
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 »
