When your CMC projects approach the final step to commercial approval - NDA submission, you need to consider how to be sure your drugs successfully reach your intended markets. 
Regulatory agencies have different requirements and timing. Trust in the right partner so you don't need to worry about the markets you are not familiar with. WuXi STA has extensive experience with all CMC activities and project planning for timely global filings.
Our dedicated drug product service package – Fast for Commercial Launch (F4CL), can support your commercial launch in global markets in parallel with speed, capability, experience, reliability and quality. 
WuXi STA has a large team of more than 1,400 formulation scientists and analytical scientists across North America, Europe and Asia to support design and implementation of your global commercialization goals. 
Our integrated API and drug product CMC platform has large teams offering high capacity and flexibility to customize plans and run in-parallel programs whenever possible to reduce time to submission.
Our formulation teams have broad dosage form capability (oral and parenteral) supported by state-of-the-art facilities equipped with commercial scale enabling technologies including spray dried dispersion and hot melt extrusion to support your selected formulation.
Our integrated teams have deep experience and know-how delivering late stage CMC campaigns supporting 42 new drugs in commercial phase.
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Our integrated CMC platform currently supports more than 1,500 new drug molecules including 47 phase III and 37 commercial projects. Globally we have supported more than 30 new drugs approved in recent years and our products have been launched in more than 105 countries.
Every facility is governed by a consistent quality system with a proven track record of approvals from all major regulatory agencies and hundreds of client audits every year.
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