Analytical Method Development
Whether you have an analytical method that needs improvement or need analytical method development services from scratch, LSNE can efficiently manage your analytical development needs and expedite your timelines. Our goal is to establish methods that provide you with consistent and reliable results as your compound progresses through the clinic. Once the analytical method has been optimized, we will deliver cGMP compliant documentation to support your regulatory filing needs.
Streamlined Analytical Method Development Services and Testing at Every Phase
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 appropriate level to include additional potency, purity or excipient analysis.
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
