The system is end-to-end and focused on speed. Our staff is empowered—we all roll up sleeves, focus and contribute. Our organization is flat, modern and agile. Our extensive experience with the FDA approval process is evident in our impressive track record. It’s a system that generates momentum and propels you to market so you can start serving patients and generating revenues.
Our on-site experts can provide a wide variety of analytics to strengthen your development programs.
In addition to maintaining FDA compliance standards, we employ an extensive quality control program.
Our multiple, state-of-the art labs provide far-reaching support for your development programs.
Successful Turnkey Approval
As a highly integrated offering, we provide complete regulatory filing services.
Our fully-outfitted and flexible cGMP facility allows us to manufacture a diverse commercial portfolio of solid dose products, including DEA-scheduled products.
Commercialization and Launch
We provide process & analytical assay validation, stability & container shipment studies, and release testing & CMC documentation.