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Drug & Device Regulatory Services
(17 Total References)
...Kathryn Rangus has worked in the areas of regulatory affairs and clinical research since 1976.Her responsibilities have included premarket approval applications, clinical trial management, quality assurance and control, preclinical testing, labeling and advertising compliance, and foreign applications.She
has prepared IND, NDA, BLA, PMA, ANDA, IDE, 510(k), and master files. Ms. Rangus received her bachelor's degree in Zoology from the University of California, Riverside; Master of Science in genetics and developmental biology from San Diego State University; and an MBA from National University. She is a member of the Regulatory Affairs Professional Society and is a certified Regulatory Affairs Professional.She is also a member of the Drug Information Association, a founding member of the San Diego Regulatory Affairs Network and a past President.Since 1989, Ms. Rangus has been President of Drug & Device Regulatory Services, Inc., which provides consulting services to pharmaceutical, biologic, and medical device companies.Kathryn Rangus
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Kathy Rangus Past President
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Kathryn Rangus, MBA, is President of Drug and Device Regulatory Services, Inc.
...Kathryn Rangus, MBAConsultantKathryn Rangus is President of Drug and Device Regulatory Services, Inc. providing regulatory affairs consulting services to the medical device, drug, and biologic industries since 1989.While employed in the industry, she directed regulatory, clinical, quality, toxicology, and pilot manufacturing functions.She is an instructor at UCSD Extension in the Regulatory Affairs Certificate Program, and a founding member and Past President of the San Diego Regulatory Affairs Network which provides educational programs to the FDA regulated industry. Ms. Rangus has an MBA, Master of Science in Genetics and Developmental Biology, and a BA in Zoology.She
is certified by the Regulatory Affairs Professional Society.
Kathy RangusPresident Drug & Device Regulatory Services, Inc.email@example.com
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* Kathy Rangus, President, Drug & Device Regulatory Services