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Extractables and Leachables Support for ENDS & e-liquid products

ExtLe Solutions Limited can provide full Extractables and Leachables project management support towards a regulatory submission for an ENDS/e-liquid product. Whether your product is aimed at the US or European markets, we will align your submission accordingly:

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• For the US market, we will ensure the E&L aspects of your submission are fully aligned to the expectations of the recent FDA Premarket Tobacco Product Applications (PMTA) guidance

• For the European market, we will ensure the E&L aspects of your submission align with the safety expectations of the Tobacco Products Directive (TPD2)

• For a smoking cessation product for the European market, we will ensure the E&L aspects of your submission meet the requirements of a Marketing Authorisation Application (MAA)  

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With our extensive experience in dealing with E&L issues related to products within the pharmaceutical industry, we will take best practice and apply it to your products, minimizing the potential for regulatory issues with the E&L content of your submission.   

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Depending on requirements, the studies we design will align with appropriate industry guidance documents, including but not limited to 

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• FDA Guidance for Industry - Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems

• EU Directive - Tobacco Products Directive (TPD2)

• EMA Guideline - Plastic Immediate Packaging Materials

• USP <1663> - Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems

• USP <1664> - Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems

• USP <1664.1> - Assessment of leachables in OINDPs

• PQRI guidance - Safety Thresholds & Best Practices for Extractables & Leachables in OINDPs

• ISO 10993-18:2020 - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process​

Select the type of support you require from the options below