[lead]Laboratory Specialists, Inc. was founded by Anthony DiFranco, a Pfizer Pharmaceutical executive and President of Sensititre Inc., and Laura M. Koeth, a Director of Technology and New Product Development for Sensititre Inc. in 1995. The mission of Laboratory Specialists, Inc., commonly referred to as LSI, is “to make a better healthcare environment by diligently working to provide the introduction of new drugs and devices.[/lead]
A majority of LSI’s work is focused on assisting pharmaceutical and diagnostic companies in the development of antibiotics and diagnostic testing devices. We also act as a central reference laboratory for four newly approved antimicrobial agents.
Our specialty is in testing antimicrobial susceptibility, performing in vitro testing, molecular detection of resistance, anaerobe susceptibility, and development of resistance studies. LSI has worked with several of the worlds largest pharmaceutical companies as well as smaller start-up ventures.
We are often chosen by smaller start-up pharmaceutical companies because we are a boutique size company with a staff of 10 people, focussing our efforts on the special needs and demands of the smaller company and their sense of urgency to meet major development milestones. We recognize critical end points and work diligently to complete project tasks.
Having launched over hundreds of new products through the FDA, we provide specials expertise in assisting in the filing of IND, NDA, PMA and 510k documents. We look at your success as a byproduct of the success we have in working on your behalf.
We also have prepared and successfully presented documents for approval of new drugs in Europe. Our familiarity with the European protocol requirements is unsurpassed.
Our success is founded on relationships we have established with clinical labs throughout the world, over the last fifteen years. The clinical labs that participate in our studies are some of the world’s most renown institutions.
We are located in Westlake, Ohio, USA with offices in Phoenix, Arizona. Our contact is on our home page. We would welcome the opportunity to be of service to you.