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Lifecycle Management for ENDS/e-liquid products

Material Changes

ExtLe Solutions Limited can provide full support towards managing the Extractables and Leachables implications of post approval material changes to ENDS & e-liquid products in North America, Europe and other territories. These post approval material changes can be due to

  • In-house material changes due to costs of goods
  • Supplier enforced material changes
  • Changes to manufacturing sites
  • Security of supply

We can also assess how other proposed post approval changes to a product might affect the Extractables and Leachables profile. For example

  • New strengths
  • Changes to e-liquid recipes

Regulatory Strategy

ExtLe Solutions Limited can design, manage and execute the Extractables and Leachables strategy for a post approval regulatory file, including authoring of the Extractables and Leachables sections. We can also help clients construct answers to any subsequent E&L related reviewer questions if required.

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