Faced with newly evolving compliance issues for e-cigarette manufacturing, a major e-liquid manufacturer hired Quantum to prepare and carry out extensive degradation studies that would identify any potential impurities of concern to the FDA.

Drawing on its extensive experience with drug impurity identification and method development, Quantum proposed an analytical strategy to meet the challenges that evolving requirements bring. Developing and executing on the study protocol, Quantum was able to support the client’s regulatory objectives.

Beyond the degradation studies, Quantum provided analytical support for the development of various product dossiers, and gave additional regulatory advice to streamline the submissions for the PMTA approval process.

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