This month we celebrate 18 years of Axendia’s contributions to the life sciences industry. Since our inception, Axendia has continuously demonstrated exceptional dedication and innovation …
Axendia’s Remarkable 18-Year Journey as Trusted Advisors to the Life Sciences Industry Read More »
A common misconception in the Medical Device industry is that FDA is impossible to interact with and that they have no interest in working with …
TAP to Break the Stigma of FDA’s Inaccessibility Read More »
We’ve all heard the term nanotechnology thrown around, but what does it actually mean? Nanotechnology is the use of materials that exist on the nanometer …
Big Things Come in Small Packages: FDA’s Approach to Nanotechnology Read More »
FDA’s Center for Drug Evaluation and Research (CDER) recently released its fifth annual report on the State of Pharmaceutical Quality. It reviews the state of …
FDA Reports on the State of Pharmaceutical Quality Read More »
The Inflation Reduction Act (IRA) will drive a significant change in the pharmaceutical industry, empowering Medicare to negotiate the prices of high-cost single-source brand-name drugs …
Price Controls: 10 Initiatives Pharma Must Consider To Mitigate Impacts Read More »
“The regulatory uses of AI are real: In 2021, more than 100 drug and biologic applications submitted to the FDA included AI/ML components. These submissions …
Artificial Intelligence has the Attention of Regulators Read More »
An Axendia “Straight from the Source” Event Axendia revealed its 2023 Life Sciences Radar on February 2, 2023, during a live event. Members of our …
Life Science Industry Predictions for 2023 and Beyond! Read More »
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 …
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 »
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 »
