Publications

Dr. Robert Schiff has published a number of articles on the subject of regulatory affairs and compliance in the pharmaceutical industry. Some may be accessed by the following links.

2010. Good Clinical Practice Compliance and the Start-up Company. Regulatory Focus. 15(5):26-32

2010. Compliance and the Start-up Company. Regulatory Focus. 15(5):8-10

2009. Medical Device Submissions. In Fundamentals of US Regulatory Affairs, 6th Ed., Berry, P.J. and Takes, eds. Regulatory Affairs Professional Society. Rockville, MD. pp.201-215

2009. Botanical Products: Drugs and Dietary Supplements. Regulatory Focus 14(8):12-16

2008. Some Thoughts on Current Good Manufacturing Practices. Regulatory Focus. 13(7):44-47

2007. Dietary Supplements: Past Compliance and the Future. Regulatory Affairs Focus. 12(12):14-16

2007. Auditing A Device Company. Regulatory Affairs Focus. 12(4):8-11