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 …
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 »
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 »
An Axendia Research Report Featuring Industry Executive Insights A top priority for patients, payers, providers, and regulators is available, affordable healthcare. The medical products1 industry …
Improving Healthcare Outcomes by Rewarding Value, NOT Cost 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 »
10 years ago, Congress provided FDA the statutory authority to conduct risk-based inspection, with the promulgation of the FDA Safety and Innovation Act (FDASIA). The …
Quality Metrics Support Improved Quality Across the Value Network Read More »
To help you navigate, Axendia will reveal its 2022 Life-Sciences Radar in this episode of our Straight from the Source series. Axendia’s analyst team will …
Plot a Course to Success in the Age of Continuous Disruption! Read More »
A Roadmap to the Agency’s Modernization Action Plans As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the …
As artificial intelligence (AI) and machine learning (ML) become more popular in the healthcare and medical device industry, their use could irrevocably change the way …
10 Regulatory Commandments of Artificial Intelligence Read More »
Veeva Vault Quality Briefing Note Axendia was recently briefed by the Executive team at Veeva Vault Quality, Mike Jovanis, Vice President of Vault Quality, Kent …
Veeva Enters Operations Execution Domain in the Cloud Read More »
