Through our cGMP analytical testing laboratories, we will reduce supply chain complexity and expedite timelines, developing product-specific methods in-house or transfer existing validated methods.
Our phase appropriate ICH validation approach for all analytical methods supports development, in-process, release, and stability testing. Our full-service laboratories are equipped with state-of-the-art instrumentation to meet testing requirements and we continually evaluate and expand our testing capabilities in-line with the growing needs of our clients.
Our Testing and Analytical Services
We provide a full analytical and Assay method development service utilizing our state-of-the-art analytical equipment to efficiently meet your parenteral development needs, providing timely, reliable, and consistent results.
At PCI, we will help you build a stability program around the specific requirements of your product and manage every aspect of the ICH stability program:
Protocol development utilizing ICH stability guidelines
All ICH conditions available in validated stability chambers
Time point management and sampling by dedicated stability team
Time point testing and data reporting with quality oversight
