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Method transfers, as a regulatory requirement, ensures a laboratory demonstrates its capability and competency to perform a method correctly. The purpose of method transfers is to avoid release of product that does not meet specification and likewise, avoid rejection of compliant product.

Whether you are looking for a new laboratory for QC release testing, or you need support on method development and validation, our team of analytical development scientists have an integrated approach for both transfers in and out of our laboratory.

Method Development

For those who are looking for method development and validation support, our team of analytical development scientists can support your requirements, and we effectively transfer methods back to your in-house laboratory or manufacturer.

Optimisation

For those who are looking to use our facility as their quality control release testing site, we will work with your laboratory to ensure a successful transfer of methods. Where challenges are encountered and investigations are required, our analytical team has the experience and expertise to troubleshoot.

How We Deliver

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Develop Protocol

We develop a protocol that is approved by both parties.

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Receive Samples

Send us samples for which we conduct testing at the same time as their laboratory on the same batch of product.

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Compare Results

We compare results with the other laboratory and ensure acceptance criteria is met.

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Investigate Anomalies

We conduct investigations and provide scientific consulting where results do not meet acceptance criteria.

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Deliver Report

The outcome of the transfer is formalised in a report for your product records.

Resources

Checklist

Download your free checklist to ensure you covered all areas for a compliant and effective test method transfer.

 

Infographic

Wondering how we can help on your drug development pathway? Download our infographic to see where our services can support you from product concept to commercialisation.

Case Study

Download our case study to read how we helped our client maintain regulatory compliance and extend product shelf-life through our method development, validation and stability management service.