Nudelman ChemTox
Consulting
Qualification of Excipients
This service evaluates the safety and suitability of inactive ingredients (excipients) at specific concentrations in drug products to ensure compliance with regulatory standards and maintain product safety.
Key Activities
Toxicological Assessment
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Evaluating the safety profile of excipients using existing toxicological data and scientific literature.
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Assessing potential adverse effects, including systemic toxicity, genotoxicity, and immunotoxicity.
Establishing Safe Use Levels
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Determining acceptable daily intakes (ADIs) for excipients based on dose, route of administration, and patient population.
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Propper use of the FDA’s Inactive Ingredient Database (IID).
Regulatory Compliance
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Aligning evaluations with guidelines from regulatory authorities such as the FDA and EMA.
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Preparing robust documentation for regulatory submissions, including risk assessments and safety justifications.
Why is Excipients Qualification Important?
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Prevents safety concerns arising from excipient-related adverse effects.
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Facilitates regulatory approval by ensuring all components of the drug product meet regulatory standards.
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Supports the development of high-quality, patient-safe pharmaceutical products.
This service is crucial for ensuring that excipients contribute positively to the drug's performance while minimizing risks to patient safety.