Regulatory filing support
ExtLe Solutions Limited can provide full or partial 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
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