Douglas Balogh
FDA Regulatory Affairs Consultant
- Role
- Senior Research Advisor at Iu Simon Comprehensive Cancer Center
- Location
- Westfield, IN, US
- LinkedIn followers
- 500 followers
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About Douglas Balogh
I’m essentially fully retired. Not taking on new clients. Not seeking new…
Experience
Senior Research Advisor
Iu Simon Comprehensive Cancer Center
Jun 2022 — Present · IN, US
Provide FDA regulatory affairs support to scientists/teams developing novel cancer treatments.
Education
The Ohio State University
PhD, Organic Chemistry
1976 — 1980
Bowling Green State University
M.S., chemistry
1974 — 1976
Bowling Green State University
B.S., Chemistry
1970 — 1974
Skills
- Therapeutic Areas
- Regulatory Affairs
- Lifesciences
- Regulatory Requirements
- Ind
- Medical Devices
- Clinical Research
- Gmp
- Glp
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- Life Sciences
- Clinical Trials
- Oncology
- Technology Transfer
- CRO
- Commercialization
- Drug Development
- Gcp
- Biopharmaceuticals
- R&D
- Formulation
- Pharmaceutics
- Drug Discovery
- Analytical Chemistry
- Verification and Validation (V&V)
- V&V
- Vaccines
- Process Simulation
- Gxp
- Chemistry
- Clinical Development
- Chromatography
- Change Control
- Good Laboratory Practice (Glp)
- Biotechnology
- 21 Cfr Part 11
- Regulatory Submissions
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