Resources

Click now to listen to Regulatory Compliance Associates' executive principal consultant, pharma and biologics, Steven J. Lynn, MS, shares his thoughts about emerging therapies, expanding cell and gene therapies on...

Q. I’m responsible for quality at a small, virtual startup company, and we contract out all of our activities. I’m working on documentation to contract out our product testing and...

In today's competitive business environment, life-science companies run lean, particularly in terms of personnel. The quality assurance (QA) function creates complexity for pharmaceutical companies because need and cost vary depending...

With the rapid evolution of technology, more and more companies in regulated industries have transitioned to an electronic medical device audit trail. This was the impetus for the U.S. Food...

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedure that holds up to...

Q. I am a quality assurance professional working for a small start-up company. I am setting up their quality management system, but I have little experience with complaint handling or...