Christopher Stewart
- Role
- Principal Consultant at Sgi Consulting, Llc
- Location
- Portage, MI, US
- LinkedIn followers
- 500 followers
About Christopher Stewart
Your Advocate in Regulatory Affairs and Toxicology at SGI Consulting. SPECIALTY:…
Experience
Principal Consultant
Jul 2011 — Present
With 30+ years of experience in toxicology, I have acquired an extensive knowledge of Good Laboratory Practice (GLP) Regulations (including requirements by the FDA, EPA, OECD, and JMHLW) and recommendations by the International Conference for Harmonization (ICH). In addition, I have contributed to the production of 300+ regulatory documents and have a working knowledge of program development/management. In the program development/management role, I primarily provide multidisciplinary advice to small pharmaceutical companies that lack their own staff toxicologist/pharmacologist. In many instances, the advice is associated with troubleshooting issues (from API production/formulation to project scheduling to addressing regulatory agency concerns to estimating a clinical safe starting dose) in an effort to keep a program moving forward.
Education
University of Arkansas for Medical Sciences
Ph.D., Interdisciplinary Toxicology
1991 — 1996
Philander Smith University
B.S., Biology
1986 — 1991
Skills
- R&D
- CRO
- Gmp
- Data Analysis
- Pathology
- Medical Devices
- Biopharmaceuticals
- Bioanalysis
- Glp
- Clinical Trials
- In Vitro
- Ind
- Drug Discovery
- Validation
- Drug Development
- Chemistry
- Biotechnology
- Human Resources
- Microbiology
- Science
- Budgets
- Laboratory
- Business Development
- Research
- Program Development
- Sop
- Regulatory Affairs
- Immunology
- Molecular Biology
- Pharmacology
- Toxicology
- Elisa
- Animal Models
- Pharmacokinetics
- Biochemistry
- Life Sciences
- Analytical Chemistry
- Hplc
- In Vivo
- Cell
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