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A key role in determining the quality of the active pharmaceutical product and drug product, is the validation of the Analytical procedure. Salzman Group specializes in developing, validating and testing of APIs and drug products, as well as various chemical tests related to medical devices.
- Assay of API and Formulated Materials
- USP/EP Drug Substance and Drug Product Testing
- Impurities & Degradation Product Analysis
- Cleaning Validation for Facilities
- Residual Solvents and OVI by Headspace-GC
- Dissolution Tests
- Loss on Drying
- Stability-Indicating Methods
- Quality Control Release & Stability Testing
Dr. Sahly has over 25 years of experience in large and emerging pharmaceutical companies in USA and Israel, amongst, worked at Pfizer as a Director of Drug Metabolism and Pharmacokinetics (DMPK), at Merck as a Senior scientists in the DMPK department and at Teva as senior Director, Head of analytical Research and Development.
Dr. Southan is a nationally-renowned pharmaceutical development leader with 30 years of professional experience in Synthetic Chemistry and Biochemistry who led numerous pharmaceutical projects from invention into Phase 2 clinical trials. Former Executive Vice-President of Chemistry at Inotek Pharmaceuticals Corporation, Dr. Southan has broad experience in the pharmaceutical development process and leads senior chemists and biologists to identify, discover, in-license, and develop innovative life science technologies.
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