FDA-inspected, in-house quality assurance testing
Your patient's safety is important to us, quality is our priority. All lots are stringently tested and no product is released before all testing is documented and complete. We strive to achieve the highest quality standards in the outsourcing industry and comply with all FDA and DEA regulations, cGMP, GDP and cGLP.
16+ ISO 5 classified aseptic
We leverage two DEA and FDA-registered and inspected 503B outsourcing facilities located in Wichita, KS and Boston, MA. Our 503B compounding facilities contain over 14,000 ft2 of space, dedicated to cleanrooms supporting cGMP 21 CFR 210 and 211 compliant operations. Each cleanroom is equipped with independent HVAC systems, state-of-the-art environmental monitoring systems and is fitted with cutting-edge automation and depyrogenation technology.
Industry leading automation
We continue to invest in and implement leading automated solutions in our compounding, filling, visual inspection and labeling processes. This automation expands our production capabilities; allowing us to offer diverse compounded sterile preparations to hospitals, ambulatory surgery centers and physician offices looking for a dependable 503B outsourcing partner.
Efficient systems to deliver superior speed of execution
We offer a variety of shipping options to fit your needs, but two-day delivery comes standard on most orders (expedited options available). More importantly, we hold a >95% same-day fill rate on orders placed before cut-off times! Low fill rates can be costly, even leading to canceled surgeries. Don’t wait weeks for your product to ship — a common problem among 503Bs. We are an outsourcing partner you can rely on.