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 cGMP 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 cGMP use, and support in-process, release and/or stability testing.