Our services and technical capabilities cover the needs for full analytical method development and phase appropriate verification to meet ICH requirements for APIs.
We know it is vital to take into account the specific needs of each project and its respective development stage. We are flexible and can change our processes to meet your pharmaceutical needs. Our extensive experience will ensure you have transferrable methods that are scientifically sound, robust, and reproducible.
We smooth the regulatory process by preparing documentation that demonstrates a clear strategy for the control of impurities originating from the starting materials, those derived from the process, and from the degradation of the product. In addition, we perform any ICH stability studies and ongoing regulatory support necessary to get your product to the clinic as safely as possible.