Other submissions teams work at arm’s length from the lab. Not ours. We embed our regulatory specialists within the R&D lifecycle from day one, ensuring that every decision made in your project’s earliest phases sets you up for streamlined FDA approval.
Our U.S.-based facilities, which offer over 100,000 square feet of flexible manufacturing capacity, are engineered to deliver safety and compliance on an accelerated timeline. Our DEA-licensed locations also welcome projects that involve Class II-V controlled substances.