RTCTox Research & Technology Center in Toxicology

Pill Identification

Sharon J. Northup, Ph.D.

Expert Toxicology Consultant / Toxicologist
	IND/NDA/510(k)/PMA Preparation Biocompatibility & Risk Analysis
Areas of Toxicology Expertise:
	Scientific and Technical Consulting in Research, Development, Regulatory and Marketing Support for Pharmaceuticals and Medical Devices Dossiers, Summaries, Expert Reports, Critical Reviews, and Analyses of Data Requirements Biocompatability Risk Analysis Design/Management of Preclinical Studies Regulatory Strategy.
Description:
	Twenty years in Biomedical R&D Developing Medical Devices and Pharmaceuticals for a Fortune 200 International Firm. 2 years Consulting. U.S. Pharmacopoeia, AAMI, ANSI, ASTM, HIMA, ISO, 10993, PDA, etc.
Contact information
	Sharon J. Northup, Ph.D. Northup Regulatory Toxicology Services 783 Ridge Road Highland Park, Illinois 60035-3847 Phone: (847) 579-0049 Fax: (847) 579-0052 Email:northuprts (at) aol.com Website: http://rtctox.com/northup.htm
Forensic Expert Witness:
	Willing to serve as Expert Witness
	Experience as Expert Witness

Dictionary of Abbreviations and Acronyms used:
AAMI	Association for the Advancement of Medical Instrumentation
ANSI	American National Standards Institute
ASTM	American Society of Testing and Materials
HIMA	Health Industry Manufacturers Association
Ind	Investigational New Drug Exemption
Iso	International Organization for Standardization
Nda	New Drug Application
Pda	Personal Digital Assistant
Pma	PreManufacture Authorization
10993	ISO-10993, Biological Evaluation of Medical Devices
510k	Fda Approval for Medical Device

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