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E&L Regulatory Support

ExtLe Solutions Limited can provide full Extractables and Leachables support for regulatory filings into North America, Europe and other territories. Working with client regulatory professionals, a strategy for the Extractables and Leachables sections of the file will be developed and executed.

If required, ExtLe Solutions Limited can:

  • Author the Extractables and Leachables content on behalf of the client
  • Assist in answering questions on Extractables and Leachables during the review process
  • ​Prepare ancillary documentation required to support Extractables and Leachables content in  preparation for PAI and/or regulatory audits
  • Provide on-site Extractables and Leachables support for regulatory inspections

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