The system is dollar-driven, 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. We’ve done the FDA rodeo so many times it’s second nature, which is one reason our track record is so impressive. It’s a system that generates momentum and propels you to market so you can start achieving revenue.
Our on-site experts can provide a wide variety of analytics to strengthen your strategic drug 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 drug development programs.
Successful Turnkey ANDA Approval
As a highly integrated offering, we provide complete ANDA filing services.
Our fully-outfitted and flexible cGMP facility allows us to maintain and manufacture a diverse commercial portfolio.
Commercialization and Launch
We provide process & analytical assay validation, stability & container shipment studies, and release testing & CMC documentation.
400 Highland Corporate Drive Cumberland, RI 02864 US