A critical component of any regulatory submission of a NDA or ANDA is the analytical quality package. At Coldstream, our skilled analytical team will develop and validate analytical methods to support the formulation process release of finished product, and ICH stability testing.
The Coldstream analytical laboratories contain state-of-the-art instrumentation, such as HPLC and GC, along with cGMP stability chambers covering -20°C, 2-8°C, 25°C/60%RH, and 40°C/75%RH. Our laboratories are also equipped with a special cytotoxic and potent handling area.
Our highly experienced staff have expertise within all aspects of pharmaceutical analytical sciences. The analytical team collaborates closely with the other Coldstream divisions ensuring success of the project with a goal of exceeding customer expectations.