Ensuring regulatory compliance and product integrity
When working with pharmaceutical products and materials there are significant, non-negotiable requirements: temperature management to protect product integrity, mandated licenses and certifications, systems and processes that conform to regulatory guidelines, and end-to-end security of the supply chain.
Everyone needs to comply – from the small biotech developing its first therapy to the largest of global pharmaceutical manufacturers with multiple, commercial brand products.
As your strategic partner, you can be assured that we have the experience and expertise it takes to serve you with outstanding accuracy, security and efficiency, whilst adhering to the strict guidelines set forth by government regulatory agencies.
Our distribution centers are strategically located in Southern New Jersey, and in Memphis, Tennessee, a major logistics hub for the United States. These facilities are heavily secured and climate controlled, featuring:
- Validated Warehouse Management System
- cGMP, GDP, PDMA and Drug Supply Chain Security (DSCSA) compliant processes
- Wholesale distribution licenses
- DEA Class III – V, TSA and VAWD certification
- Designated areas for quarantined/high-level security storage
- Managed environments for Ambient (15°C to 30°C), Refrigerated (2°C to 8°C) and Frozen (-25°C to -10°C) storage
We ensure optimal quality and capacity at our flagship Memphis facility by employing advanced automation, including pick-to-light / put-to-light systems and RF technology. We have made significant investments in support of the increased demand for cold chain services by expanding our refrigerated/frozen storage and providing zero Time Out of Environment (TOE) pick and pack services. Our continued investment in cold chain storage and distribution mirrors the industry's evolution to handle increased quantities of complex cold chain biologics.
Whether managing commercial pharmaceutical samples, finished goods, or ancillary materials, we have a track record of delivering industry leading service with impeccable quality standards.