Fast for Commercial Launch
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F4CL - Fast for Commercial Launch
Drug Product Service Package Designed for Fast Commercial Launch to Global Markets
When your CMC projects approach the final step to commercial approval – NDA submission, you need to consider how to ensure your drugs successfully reach your intended markets.
Regulatory agencies have different requirements and timelines. Working with the right partner, and so you don’t need to worry about the markets you are not familiar with. WuXi STA has extensive experience in all CMC activities and project planning for 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, reliability and quality.
Why rely on F4CL for your commercial launch?
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.
Speed
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.
Capability
Our formulation teams have broad dosage form capability 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.
Experience
Our integrated teams have deep experience and know-how delivering late stage CMC campaigns supporting 58 commercial projects.
Reliability
Our integrated CMC platform currently supports more than 2,700 drug from preclinical to phase III and 56 commercial drugs. Globally our products have been launched in more than 105 countries.
Quality
Every facility is managed by a consistent quality system with a proven track record of approvals from all major regulatory agencies and hundreds of client audits every year.
