The Connected Device Journey Join industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) for a free, 3-day virtual symposium May…
RCA experts answer questions about the recent FDA 21 CFR 211.110 guidance document and how it relates to drug shortages.
Join our expert panel of scientists and FDA consultants as they explore the potential regulatory changes with the new administration.
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and…
In this PharmTech interview the topic of advances in small-molecule manufacturing is covered with several other experts commentaries.
This presentation provides an overview of the FDA's device pre-submission process and will examine the advantages of the Q-Sub program.
In this Ask the Expert video, experts discuss the new chapter, Chapter Bacterial Endotoxins Test Using Recombinant Reagents.
Click to learn how RCA's regulatory compliance consultants approach the MDR submission process & clinical evidence requirements for CE Mark.