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