ExtLe Solutions Limited provides full support towards managing the Extractables and Leachables implications of post-approval material changes to client products in North America, Europe, and other territories. These post-approval material changes can be due to
- In-house material changes due to costs of goods, manufacturing site changes, security of supply, etc…
- Supplier enforced material changes
We can also assess how other proposed post-approval changes to a product might affect the Extractables and Leachables profile. For example
- Tech transfers
- New dosage forms
- New strengths
- Excipient changes
ExtLe Solutions Limited can design, manage and execute the Extractables and Leachables strategy for a post approval regulatory file, including authoring of the Extractables and Leachables sections. We can also help clients construct answers to any subsequent reviewer questions if required.
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