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Method Validation

 

 
Drug candidates entering late phase clinical trials require validated analytical methods to prove adequate precision, accuracy and robustness. Micron Technologies provides the resources and expertise to rapidly turnaround validation studies for methods developed in-house or at customer laboratories.

We are a leader in method validation for those techniques commonly used in the physical characterization of drug substance and drug product. We have developed well established validation protocols that ensure accuracy and reproducible results. With two laboratories, each equipped with the latest laser diffraction equipment, we have the resources to deliver method validation studies for particle size analysis quickly and efficiently. For these reasons, many pharmaceutical companies are outsourcing their requirements for method validation of such techniques to Micron Technologies.

With extensive analytical capabilities, in addition to stability monitoring facilities, we are also well positioned to service our customers’ needs in the areas of product release and stability testing.

We work closely with our customers in developing validation protocols to meet the most rigorous regulatory requirements.

Micron Technologies can carry out method validation as a stand alone service, independent of any micronization services. Method transfer studies are also offered for those methods not requiring rigorous re-validation.