Our Mission: Your Success
The laboratory’s mission is two-fold: 1) to provide high-quality clinical laboratory testing for means of clinical diagnosis to assist clinicians in practicing cost-effective medicine and 2) to provide biotech start-ups and small to mid-size companies the necessary resources and expertise for the development and commercialization of concepts, including services up to and including FDA approval, in areas of interest including clinical diagnostics, medical devices, cosmetics, and food testing, in a highly professional, expert-driven, and cost effective manner in compliance with all applicable regulatory bodies.
HOW IT FITS TOGETHER
Our Contract Research Services team provides a full suite of resources from laboratory services and test development to support for product development projects. We can initiate projects quickly, reduce risks and avoid unnecessary costs. Often it works closely with our Clinical Diagnostics team to coordinate clinical projects that require and benefit from both a research laboratory and a CLIA facility.
Our Clinical Diagnostics (CDx) team supports and works closely with Contract Research Services and throughout the pandemic has risen to the occasion to support our local communities by providing Covid-19 testing (RT-PCR, antibody testing and our patent-pending protective antibody test). We have provided testing throughout the pandemic and will continue to support our local physicians and patients with a quick-turnaround test option. Our CDx laboratory provides an extensive menu of allergy and autoimmune diagnostic tests.
DevLab endeavors to provide start-ups, small and mid-size companies the necessary resources to simply design an assay to meet your need or develop a series of tests to confirm benchmarks for your project. We can support and assist in commercializing concepts and producing new products. We can provide development and commercialization services and support from concept to prototype, from prototype to product and from product to commercialization. Additionally, we support you with a comprehensive services suite including Molecular Diagnostics, Immunoassay and antibody generation and a range of development services. Through partnerships, we can provide a route to FDA approval. Unlike the traditional CRO, our agility and flexibility benefits both small and large customers. We assist with experimental design and have the facilities and capabilities to take a customer’s idea from concept to commercialization in a variety of disciplines.
Our commercialization support includes evaluating technologies, scientific and product expertise support, project management and laboratory facilities for building and testing products. DevLab provides business infrastructure and marketing guidance. We provide IP support and operate with regulatory expertise in CAP/CLIA, GLP/GMP and ISO compliance.
DevLab, LLC is a CAP/CLIA accredited laboratory and currently performs all services adhering to Good Laboratory Practices (GLP).
DevLab expects to be ISO 17025 accredited by third quarter 2022.