LITHICUM, MD / CSSi LifeSciences, a global drug and medical device contract research organization (CRO), and DevLab bio, a CAP accredited and CLIA certified contract research laboratory, announced today their partnership to provide seamless and integrated regulatory and analytic testing and development services to medical device and drug companies seeking to commercialize novel technologies.
CSSi LifeSciences has advanced hundreds of drugs and medical device technologies from discovery to commercialization. The partnership expands CSSi LifeSciences client services to offer fully integrated contract analytic development and safety monitoring—speeding up the product development process.
“The pandemic helped us realize how important it was to get lifesaving technologies on the market faster,” said Sam Sutton, Chief Executive Officer of DevLab bio. “We knew, together, we could help companies make that happen and cut their time to commercialization in half.”
The CSSi LifeSciences and DevLab bio partnership will accelerate its client’s regulatory pathway to commercialization: CSSi LifeSciences will identify the regulatory requirements needed to meet FDA guidelines and DevLabs bio will seamlessly conduct the testing and provide the qualified reporting required by the U.S. FDA. In addition, the companies are codeveloping a number of new biomarkers and multiplex rapid antigen test kits for emerging infectious diseases.
“The pathway to commercialization for new drug or medical device companies is costly, labor intensive, and prone to risks due to complex regulatory requirements for clearance,” said Jim Sergi, President of CSSi LifeSciences. “Our combined expertise with DevLab bio will exponentially accelerate product timelines, while reducing costs and analytic data to support patient safety and successful regulatory submissions, all at a reduced cost then if companies did it themselves,” said Sergi.
Both companies will be attending the BIO 2022 in San Diego and DIA 2022 Global Annual Meeting in person this June 19-23, 2022, in Chicago, IL, Booth 1039.
All preclinical stage drug and medical device technologies are required by the FDA to perform analytical testing by an FDA qualified vendor prior to moving into a Phase I clinical trial. CSSi LifeSciences and DevLab bio’s partnership will provide drug and medical device companies full regulatory support, analytical benchtop testing, and clinical trial sample processing. They will also provide a Quality Management System to clients wishing to commercialize technology in the US. Together, this partnership will enable companies to ensure their technologies are developed and tested following FDA regulatory guidelines in a one-stop, integrated manner.
In addition to CSSi LifeScience’s regulatory affairs, project management, clinical trials, and commercialization contract services, this new partnership will now offer clients:
- Contract research laboratory and a high complexity, CAP Accredited (#8835544) and CLIA certified (#45D2187554) clinical laboratory services, including proof of concept, 510(k), EUA and LTD services
- Molecular assay or immunoassay development and/or clinically regulated support
- Genomic research services, including DNA/RNA Extractions, PCR/QPCR/RT-PCR and Next Generation Sequencing
Immunoassay Services include Cell Culture, ELISA and Custom Assay Development
About CSSi LifeSciences:
CSSi LifeSciences is a global research services provider that has successfully advanced hundreds of drugs and medical device technologies from discovery to commercialization. CSSi LifeSciences provides services across all phases of drug and medical device development, including filings to regulatory bodies in the United States and abroad, clinical study planning and monitoring, medical device testing, design history files, quality management systems, reimbursement, and more. It has navigated drug and medical device regulations in over 100 countries and has a portfolio that includes over 300 drugs and medical device technologies. Its mission is to empower innovators with the expertise, skills, and network that accelerate novel therapeutics and medical devices to market.
The company’s headquarters is located in Linthicum, MD, with additional offices in San Francisco, CA and Hyderabad, India. For more information, visit www.cssilifesciences.com, email [email protected], or call Jim Sergi at (415) 317-4903.
About DevLab bio:
DevLab bio is a contract research laboratory with a high complexity, CAP Accredited (#8835544) and CLIA certified (#45D2187554) clinical laboratory. With its highly skilled team, it provides molecular assay or immunoassay development and/or clinically regulated support services. Its contract research laboratory services includes: proof of concept, 510(k); EUA and LTD services; genomic services, such as DNA/RNA Extractions; PCR/QPCR/RT-PCR and Next Generation Sequencing. The company works with a variety of Immunoassay Services include Cell Culture, ELISA and Custom Assay Development. For more information visit: https://devlabbio.com/ or email [email protected].