51ÁÔÆæ

Cell and Gene Therapies also known as (ETMPs) have continued to evolve in recent years. Over the last 15 years the industry and regulatory bodies have continued to learn more...

Click now to learn from Sue Schniepp, Distinguished Fellow at 51ÁÔÆæ, as she describes microbial process design and how your team can improve contamination control. Human microbes live...

During times of crisis — such as the global pandemic — keeping supply chains moving becomes even more important. Issues with supply chains can lead to critical shortages of items...

Click to watch 51ÁÔÆæ medical device consultant, Dr. Stephen Coulter, discuss the common tools & processes used during product development. Early stages of new product development include analyzing...

Click now to listen to 51ÁÔÆæ's Director of Regulatory Affairs, Jordan Elder, in this 51ÁÔÆæ Radio audio update: The European Parliament recently voted for a timeline extension to MDR regulation,...

The pharmaceutical and biologics industry recently received updated FDA guidance on the use of Generally Accepted Scientific Knowledge (GASK) in regulatory submissions. The FDA guidance provides new examples of when...