For more than 10 years, GSD has served many diagnostic markets, including physician-owned laboratories, large and small hospitals, and reference laboratories. Our broad menu of assays offers the laboratory a range of choices to improve efficiency, increase revenue or expand their test offering.
With clients in all segments of the clinical diagnostic market, our invaluable insider market knowledge enables us to reach virtually any potential customer. GSD’s technical and sales teams have relationships with key decisions makers in every market. We also have extensive market information regarding Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs). We also leverage distribution channels to expedite access to valuable accounts.
Our experience in successful product clearance makes us the partner of choice for manufacturers seeking FDA clearance for their products. Our expertise with U.S. FDA and FDA 510(k) clearance encompasses all aspects of the approval process, including assay requirements, predicate devices, IRB, clinical trial study design, submission documentation and FDA communication. We successfully combine customer needs with product clearance, to bring the best products from our partners to the U.S. market.
As an ISO certified company with a strong Quality system and Regulatory Affairs department, we can effectively navigate the maze of CLIA and FDA regulations. From filing for a new product to assisting end-users with in-lab validation requirements, our in-house quality and regulatory teams have years of experience.