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Sharon J. Northup, Ph.D. |
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Expert Toxicology Consultant /
Toxicologist |
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- IND/NDA/510(k)/PMA Preparation
- Biocompatibility & Risk Analysis
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Areas of Toxicology Expertise:
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- 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.
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Description: |
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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. |
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Contact information |
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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
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Forensic Expert Witness: |
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Willing to
serve as Expert
Witness |
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Experience
as Expert Witness |
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Dictionary of
Abbreviations and Acronyms used: |
| AAMI |
Association for the Advancement
of Medical Instrumentation |
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ANSI |
American National Standards Institute |
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ASTM |
American Society of Testing and
Materials |
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HIMA |
Health Industry Manufacturers
Association |
| Ind |
Investigational New Drug Exemption |
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| Iso |
International Organization for
Standardization |
| Nda |
New Drug Application |
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| Pda |
Personal Digital Assistant |
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| Pma |
PreManufacture Authorization |
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10993 |
ISO-10993, Biological Evaluation
of Medical Devices |
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510k |
Fda Approval for Medical Device |