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Development Services

An extension of your lab

Anatomy of a Synthesis and Process Development Project

Our success at developing active pharmaceutical ingredients for our clients is the result of our highly interactive team of experts–experts in synthesis reactions, process optimization and analytical methods development. We come together early and often, working in parallel and thinking ahead to ensure that when we’re finished with your project, you have everything you need to move ahead.

Synthesis Scouting Services

• Develop and screen potential synthetic paths

• Synthesize or isolate by-products of the reaction or degradation

• Custom-synthesize standards or pre-clinical materials

• Investigate extraction, isolation and purification processes for synthetic or biological-sourced materials

Analytical Methods Development Services

•	Develop analytical methods, entirely or in part
•	Perform forced degradation studies that support method selectivity
•	Characterize impurity profiles
•	Characterize reference standards
•	Evaluate intermediate precision of methods

Process Development Services

•	Troubleshoot synthetic processes
•	Troubleshoot pharmaceutical processes
•	Optimize process parameters
•	Conduct extended process parameter range studies
•	Conduct compatibility studies, such as API compatibility with excipients
•	Investigate new raw material sources or changes to existing raw materials

Clinical API Supply Services

•	Manufacture cGMP grade API for clinical studies

Whether we’re taking a client from synthesis scouting through clinical API supply and scale-up or just one phase in the process, we think beyond the pure chemical. Our research and technology experts work with a “final dose” mindset to give you practical answers to your development and delivery challenges.