Resources

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...

In this episode of PharmTech’s Pharma Fundamentals, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates and a member of PharmTech's editorial advisory board, and Amnon Eylath, president and founder...

In this audio clip originally published by by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies...

This Video was published by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust...