Contract Drug Substance Development & cGMP Manufacturing

Founded in 1962 and headquartered in Riverview, Michigan, Ash Stevens has a long and successful history of working with Life Science companies of all sizes, translating development candidates to commercial realities. To date, Ash Stevens has an impressive track record of twelve regulatory manufacturing approvals for innovator APIs (all NCEs). This includes the recent  accelerated approval (December 2012) of ARIAD Pharmaceuticals’ drug Ponatinib (Iclusig™) for the treatment of hematological cancers. Ash Stevens has multiple API approvals for FDA Fast-Tracked drugs developed under signifi cantly accelerated timelines, including the four Fast-Tracked drugs: Velcade®, Vidaza®, Clolar® and Iclusig™.

Ash Stevens is a fully cGMP-compliant operation offering regulatory support spanning early-stage drug substance development through NDA registration and post-approval manufacturing. We have a long history of successful inspections by worldwide regulatory agencies that include Australia, European Union, Japan, Korea and Mexico. We are also experts at preparing documentation for regulatory filings according to current standards.

With more than fifty years of experience in the design, development and execution of robust cGMP manufacturing processes, Ash Stevens has the technical expertise and capability to  address the most challenging chemical and manufacturing bottlenecks and timetables.