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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 

Click on the button below to arrange an initial no obligation discussion of your requirements.

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