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. |
Method Validation
