Resources

Selecting the right ingredient suppliers is an important part of building a reliable and resilient pharmaceutical supply chain. In this Ask the Expert discussion, Jane Zhang, co-founder and co-CEO of...

Pharmaceutical companies operating in global markets must understand how international pharmacopoeias influence product quality, testing requirements, and regulatory compliance. In this Ask the Expert discussion, Susan J. Schniepp of RCA...

Pharmaceutical manufacturing processes naturally evolve as companies increase production, optimize processes, and adopt new technologies. In this Ask the Expert discussion, Susan J. Schniepp of RCA and Siegfried Schmitt of...

Are Pharmaceutical Companies Required to Comply With Pharmacopeias? Understanding pharmacopeial requirements can be more nuanced than simply determining whether compliance is mandatory. In this Ask the Expert discussion, Susan J....

Integrating FDA Compliance Into Medical Device Development From Day One For medical device startups and early-stage companies, overlooking regulatory requirements during product development can lead to unexpected costs, extended timelines,...

In this audio clip originally published by by PharmTech. Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished...