E&L for ENDS & e-liquids | ExtLe Solutions

Extractables and Leachables Support for ENDS & e-liquid products

ExtLe Solutions Limited can provide full or partial 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:

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)

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:

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

Lifecycle Management

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