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 client laboratories.
We are a leader in method validation for those techniques
commonly used in material characterization of drug substance and
drug product, including particle size analysis and surface area
analysis. With expanding chromatography capabilities and laboratory
space, we are now positioned to better service our client’s needs
in the areas of product release and stability testing as well.
We work closely with our clients in developing validation
protocols to meet the most rigorous regulatory requirements.
Method transfer studies are also offered for those methods not
requiring rigorous re-validation. |
