Offering compounded pharmaceutical medications designed specifically for the patients who receive them – be they pediatric or adult – can make a powerful difference in their treatment and lives.
Providing the right dosage of medication available in pre-filled syringes produced in a sterile, cGMP-compliant 503B facility gives doctors – and their patients – an added level of safety and confidence in the operating room. At STAQ, injectable pediatric concentrations – developed with guidance from Children’s Hospital Colorado – are created specifically for pediatric patients. And adult concentrations are available for adults. Have a specific need? Let us know so we can work together to determine viability and production as appropriate.
Every patient deserves the right anesthesia medication, in the right concentration and volume, packaged for safe and effective administration, at the right time.
Let’s be clear.
From the glass panes in our pharmaceutical facility to the COAs (certificate of analysis) we provide with every batch and detailed quarterly quality management reports we post online, STAQ is committed to transparency. Our e-procurement system puts access to your production and shipping status, past order history, COAs and all other documentation right at your fingertips. Want to see our highly automated compounding process for yourself? We encourage visits to our inspection-ready Denver office.
Everything at STAQ has been designed and built to comply with FDA regulations, so our award-winning cGMP facility has nothing to hide.
Working to eliminate waste and shortage issues.
Having the medications you need available when you need them is, simply put, essential. That’s why we’ve put systems in place to help support and even anticipate your compounded pharmaceutical needs.
Onsite production of one drug at a time per room. Inventory systems to forecast needs and proactively provide partners with critical product. Capacity to produce up to 30,000 pre-filled syringes a day at full build out. And an active product development committee comprised of hospital and pharmacy representatives with a pulse on the most urgent pharmaceutical compounded medication needs.
With its central location in Denver, Colorado, STAQ Pharma can quickly and efficiently access and support hospitals across the United States.
Setting the bar higher.
STAQ’s goal from day one has been to help ensure the highest possible quality of surgical medications for children and adults. Built brand new as a 503B and focused on the most current FDA guidance, we’re poised to do just that.
With more than 4,500 square feet of highly automated ISO 7 and ISO 8 cleanroom space and an extensive Quality Management System operation, STAQ’s outsourcing facility is designed to meet the highest of industry standards.
We conduct independent testing analysis to ensure stability, sterility, potency and lack of endotoxins on every batch of medication we compound. And, each syringe we fill is individually inspected and verified before it can pass from our doors to yours. Plus, we have integrated robotics to minimize human touch and maximize accuracy and efficiency. Simply put, STAQ provides top quality pharmaceutical compounding with state-of-the-art manufacturing.
Meeting standard expectations is important. But you – and your patients – deserve even more.
A lot goes into being a 503B cGMP facility.
STAQ is proud to be one of the country’s first 503Bs designed and built from the floor up to comply specifically with FDA regulations as a cGMP facility.
Late in 2013, in response to then poor oversight by the state boards of pharmacy, the Federal Drug Administration (FDA) implemented the Drug Quality and Security Act (DQSA) and broke pharmaceuticals into two sectors: 503A and 503B. Pharmaceutical outsourcing facilities like STAQ, which compound, manufacture, and sell medications in large batches to healthcare facilities were required to be, or become, 503B. For most pharmaceuticals, this meant converting their existing 503A facilities to conform to the new regulations and standards.
We created STAQ as a 503B from the start, meaning our 18,400 square foot facility was specifically built and designed to meet the highest safety and regulatory requirements. We maintain full compliance with current good manufacturing practices (cGMP), keep stringent reporting systems, are prepared for onsite facility inspections, adhere to all FDA regulations associated with the bulk drug substances we compound, and have a robust adverse event reporting system in place.
Rest assured. STAQ is committed to meeting the highest standards of quality control and patient safety. It’s in our name.