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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