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Post Approval Life Cycle 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

Regulatory Strategy


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.

Click on the button below to arrange an initial no obligation discussion of your requirements.

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