Ash Stevens is a global provider of contract drug substance development and active pharmaceutical ingredient (API) manufacturing services. With more than 50 years of experience, the company has achieved an impressive track record of manufacturing approvals for innovator APIs (all NCEs) including multiple API approvals for FDA fast-tracked drugs developed under significantly accelerated timelines. Ash Stevens’ state-of-the-art manufacturing facility in Riverview, Michigan has the capability to manufacture APIs on a scale of grams to hundreds of kilos including highly potent active pharmaceutical ingredients (HPAPIs). Ash Stevens supports all aspects of drug substance development and manufacturing, from de novo process development to commercial API production including quality by design (QbD) process risk mitigation approaches. Analytical support includes methods development and validation, stability testing, solid state characterization, and ICP/MS testing for heavy metals.