- Salzman Group -
Salzman Group operates as a GLP/GMP/GCP compliant CRO in order to provide a complete drug development package to clients. Our dedicated Quality Systems Department ensures precision and accuracy, intended to support the innovative projects of our clients. Using a unique multi-disciplinary approach allows flexibility and personalization, while staying compliant with regulatory guidelines.
Our GLP/GMP world class Quality Control (QC) laboratory specializes in cutting-edge development and performance of complex analytical and bio-analytical methods in order to attain extreme sensitivity and selectivity of analytes in various matrices. In support of these objectives, the laboratory utilizes high-end instrumentation including: 5 Agilent LC-MS/MS, 25 Agilent HPLCs and UHPLCs, a state of the art high resolution time of flight Agilent mass spectrometer, 400 and 600 MHz 2-dimentional NMR, FTIR, 3 Agilent GC-MS, an Agilent thermal decomposition unit (TDU), as well as laser scattering (LDSC), ultra violet (UV) detection systems.
Our research team has 15 experienced analytical chemists dedicated to method development, led by our executive VP of research, Dr. Garry Southan, a nationally-renowned scientist, continuously funded by the national institute of health (NIH) for more than over 25 years. The Quality Control department in tightly integrated with the divisions of medicinal chemistry and synthetic chemistry, allowing for ready access to customized preparation of reference standards, impurities, degradation products and metabolites. The medicinal chemistry group has special expertise in the invention and preparation of novel derivatization, allowing for the conversion of difficult-to -analyze materials into highly detectable analytes, often in the low picomolar range. Our group especially excels in developing sensitive and selective bioanalytical methods in standard biological matrices (plasma, urine) in various species, as well as in target tissues, while successfully tackling complex obstacles such as efficient extraction and stabilization of target molecule in the testing matrix. As support to synthetic chemistry procedures, the research team routinely perform solubility and stability testing, salt screening, morphology studies, composition and impurities identification, formulation development and prodrug evaluation and characterization.
Validation & Testing
As one of the largest QC laboratories in this geographic region, we have tremendous capacity handling various studies such as: full validations, release testing of API and related substances, COA issuance, formal stability studies (long term, accelerated, stress), dose verifications, and processing of large volumes of biological samples of various matrices from both clinical and pre-clinical investigations. All studies in the QC laboratory are executed according to quality manuals and standard operating procedures (SOPs) composed by our regulatory affair specialists. All methods, data, and results are documented and archived by our QA unit. We guarantee services that are compliant with any regulatory requirements in all major international markets.
Salzman Group's Quality Assurance (QA) unit closely monitors methods, procedures, and studies throughout all stages of the drug development pathway. Our seasoned QA team is responsible for routine reviews and documentation of all research, testing, and manufacturing activity at our facilities, and also performs regular internal audits in preparation for external inspections and audits by regulatory authorities. The QA team supervises the design, execution, and reporting of analytical and bioanalytical testing conducted at our GLP/GMP compliant Quality Control laboratory.
Our Quality Systems unit is headed by Gali Guzikevich, Ph.D. Dr. Guzikevich is a chemist with more than 15 years of experience in the pharmaceutical industry. She earned her doctoral degree in structural biology and Chemistry from the Weizmann Institute of Science. Dr. Guzikevich is an expert in Quality Assurance and Regulatory Affairs, and has a profound knowledge in international pharmaceutical Guidelines, including GMP and GLP standards. Dr. Guzikevich successfully led dozens of FDA, European, Israeli, and other Health Authorities Inspections. She played leading roles at big pharmaceutical firms, including QA of commercial GMP facilities, QC laboratories, development manufacturing plants, and R&D laboratories. She believes in constantly striving for improved quality; and established and sustained quality culture throughout the company.
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