Nudelman ChemTox
Consulting
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About Us
Nudelman ChemTox Consulting is a scientific and regulatory consulting firm specializing in impurity qualification and risk assessment for pharmaceutical drug substances and drug products. The firm's team of PhD-level scientists, with backgrounds spanning chemical toxicology, molecular biology, immunology, and organic chemistry, delivers expert assessments aligned with current ICH, FDA, and EMA guidelines, supporting pharmaceutical and biotech companies in achieving safety and regulatory compliance worldwide.
The firm's core expertise covers the full spectrum of pharmaceutical impurities: mutagenic impurities (ICH M7), including in silico QSAR-based assessments using lead QSAR tools; nitrosamine risk assessment and mitigation; non-mutagenic impurities (ICH Q3A/B); residual solvents (ICH Q3C); elemental impurities (ICH Q3D); and extractables & leachables (ICH Q3E). The team also specializes in excipient qualification and in the determination of Occupational Exposure Limits (OELs), Acceptable Daily Exposures (ADEs), and Occupational Health Categorization (OHC) bands - health-based exposure limits essential for safe pharmaceutical manufacturing operations.
Beyond consulting, Nudelman ChemTox Consulting offers customized in-person and online training programs for pharmaceutical professionals and organizations, covering topics from ICH M7 mutagenicity assessment and nitrosamine risk evaluation to E&L interpretation and OEL derivation - empowering teams to apply best practices directly in their workflows.
Having supported more than 100 pharmaceutical and biotech companies globally across hundreds of assessments, Nudelman ChemTox Consulting combines deep scientific rigor with practical regulatory experience to deliver precise, reliable, and defensible solutions that meet the highest industry standards.
Noga Kaufman
PhD, Computational chemical toxicologist
Noga Kaufman is an expert in organic and bio-organic chemistry, holding a PhD in Bio-Organic Chemistry from Bar-Ilan University.
Before joining Nudelman ChemTox Consulting, Noga gained hands-on experience in synthetic organic chemistry and advanced characterization techniques including MS, LCMS, and NMR.
Currently, Noga’s work focuses on computational toxicology, applying QSAR analyses and tools such as DEREK and SARAH to assess and control DNA-reactive (mutagenic) impurities in pharmaceuticals, helping to limit potential carcinogenic risk in line with ICH M7 guideline.
Raphael (Raphy) Nudelman
PhD, ERT, CEO Nudelman ChemTox Consulting
Raphael (Raphy) Nudelman is a chemical toxicologist with over 20 years of industry experience. He holds a PhD in organic chemistry from the Weizmann Institute of Science and completed postdoctoral research at the US Air Force Research Lab and Duke University Medical Center.
At Teva Pharmaceutical Industries, Raphy held various roles, including in the medicinal chemistry department, the patent department, the non-clinical safety department, and as the Impurity Expert of the company. His expertise spans impurity and excipient qualification in drug substances and drug products, with a recent focus on risk assessment of nitrosamine impurities in pharmaceuticals. Raphy retired from Teva in September 2024 and founded Nudelman ChemTox Consulting, where he continues to provide consulting services in the pharmaceutical impurity qualification field.
Alon Nudelman
PhD, VP Nudelman ChemTox Consulting
Alon Nudelman is a molecular biologist with expertise in immunology, biochemistry, and protein biology. He holds a PhD in Molecular Biology and Immunology from the Weizmann Institute of Science.
Before joining Nudelman ChemTox Consulting, he held research positions in the biotech industry, specializing in mRNA-based cancer therapeutics and nanobody biochemistry. He also has experience in occupational toxicology, focusing on impurity risk assessment and exposure limit determination.
As VP of Nudelman ChemTox Consulting, Alon contributes his expertise in pharmaceutical impurity qualification, occupational toxicology, and risk assessment strategies.
