Analytical Method Development for Sterile Products

Through our GMP 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.

We have extensive expertise in analytical method development. We can develop a method from scratch or transfer and optimize an existing method, providing consistent and reliable results as a product progresses through the clinic and delivering GMP compliant documents to support regulatory filing.

We support early phase development as part of your IND or optimize methods developed by your API or BDS vendor. We can enhance assays to their required phase to include additional potency, purity or excipient analysis.

Streamlined Testing at Every Phase

• Drug substance/API identification & release testing
• Drug product in-process, release, and stability
• Raw materials – excipients and intermediates
• Reference standard qualification
• Cleaning method development and verification/validation
• Forced degradation studies
• Impurity profiling
• Material compatibility
• Spike and recovery Studies

Analytical Method Qualification and Validation

Existing methods transferred in and methods we develop in-house are validated according to phase appropriate approaches for GMP use, and support in-process, release and/or stability testing.

Our dedicated team of specialists will be happy to discuss our Analytical Method Development services with you. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com