Richard A. Angelo, Ph.D.

Dr. Angelo holds Master of Science and Doctor of Philosophy degrees in Microbiology from the Universities of Missouri and Kansas, respectively, and was a biochemistry post-doctoral research fellow at Purdue University.

 

His more than 30 years of regulated product development experience in the pharmaceutical, biologic and medical device industries in operational, senior operational, executive leadership and senior consultant roles brings a wealth of value and expertise to your program.  His industry tenure includes leadership positions in publicly traded US prescription product and OTC development corporations as well as full-service contract research organizations.  He has led regional, national, and international multidisciplinary development teams in a variety of therapeutic areas.

Product development consulting services include areas such as clinical program design and planning, regulatory strategy, clinical quality compliance oversight and commercial readiness.  Compliance focus includes quality system audits, Good Clinical Practice audits, Good Clinical Laboratory Practice audits, Good Tissue Practice audits, Good Pharmacovigilance Practice audits, and Quality System Regulation (21 CFR 820) Audits.  Mock pre-approval regulatory agency inspections are offered to ensure compliance with FDA regulations, quality standards and harmonized international industry guidance documents.

He was the principal author of Chapter 16, Medical Device Compliance and Postmarketing Activities, in Fundamentals of US Regulatory Affairs, Seventh Edition, 2011, a Regulatory Affairs Professionals Society (RAPS) publication.  He founded NOVA Clinical Research Support, LLC consulting practice in 2004.

Curriculum Vitae

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