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Regulatory filing support

ExtLe Solutions Limited can provide full Extractables and Leachables support towards regulatory filings into the United States, the U.K. or mainland Europe. 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 of the submission on behalf of the client

  • Assist in answering any questions related to Extractables and Leachables during the review process 

  • Design and support any potential control strategy for the materials used in the product 

 

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

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