Lifecycle Management

Material Changes 

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