Hazardous Material Handling - Streamlining Complex Regulatory and Compliance Issues

Case Study

The Project Situation

A large life science corporation developed a set of reagents used for the operation and maintenance of their instrumentation platform. A key ingredient in the formulation of the instrument wash buffer was a biocide, a chemical regulated by a variety of local, national, and global directives. The client sought a simple solution, not wanting to deal internally with the complex warehousing, logistics, and regulatory requirements for distributing the regulated material. In addition, as a key strategic priority, the client was working towards receiving regulatory approval to allow use of their instrument in clinical labs and diagnostic applications, so they had specific quality needs for the reagents used in the assays.

Our Operational Support

We used a cross functional product development team including members from production, marketing, QA, QC, regulatory, and supply chain to consider all the client needs as part of creating a customized solution. The specific quality requirements, regulatory challenges, and global logistics were all considered as part of the process.

The Customized Solution

We developed a project plan that addressed all the current and future customer needs. At the client's request, the end product formulation was slotted into our Diagnostic Elite product line, a catalog of raw materials and formulated reagents specifically designed for clinical testing and IVD applications. The team was able to leverage our extensive experience in manufacturing, logistics, regulatory compliance, and global distribution of chemicals. At the client's request, the material was added to our product catalog, allowing for simple ordering and fulfillment worldwide and minimized cost, allowing their customers to access the reagents in a simple and affordable manner. Most critically, the client was able to turn over the complex regulatory process to the experts at our company, making the reagent ordering process simple for the end user, and removing the regulatory burden from the client's own internal teams.

Results

The successful product launch has led the client to consider what other reagents supporting their instrument platform can be outsourced to us, allowing them to focus on innovating and supporting their instruments. Our regulatory support of has given them confidence that they can access our entire product catalog for reagent development, knowing they have a viable commercial partner to help them navigate even the most complex logistic and regulatory hurdles.