Lakeside Life Science Services
AN ORGANIZATION DEDICATED TO IN VITRO DIAGNOSTIC TESTING WITH RECOGNIZED EXPERTS IN COMPANION DIAGNOSTICS AND PERSONALIZED MEDICINE
Lakeside Life Science is committed to providing optimal solutions including the earliest stages of discovery research. With many years of laboratory experience in the development of novel tests and test formats, Lakeside provides experienced guidance and a full service laboratory to discover and optimize novel assays including immunoassays, molecular genetic testing, and Point of Care technologies
At Lakeside we have the experience you need to complete the Product Development phase for your laboratory test. With an extensive Quality Management System we can help you scale-up your novel assay using an FDA compliant Product Development Process under strict Design Control.
We help with scale-up challenges, product documentation, and will bring your test forward to the Commercialization Phase.
Lakeside has extensive experience with Analytical Validation of IVDs. We have template protocols for all technologies including chemistries, immunoassays, RNA-based microarrays and DNA-based PCR assays including NGS.
Rely on our expertise and experience to write FDA-compliant protocols, conduct testing in our laboratory, prepare detailed reports and incorporate all required information into FDA submittable documents.
Lakeside Life Science Clinical Trial Services are dedicated to the development of Laboratory Tests by leveraging over 100 years of our teams combined clinical and regulatory expertise. Our relationships with clinical centers, patients and clinical laboratories has led to novel approaches to implementation of clinical studies. As a result, we complete studies faster and at lower cost.
Regulatory Strategy and FDA Submissions
For those developing Companion Diagnostics or Stand Alone IVD's, FDA approval is often a barrier to success. At Lakeside, we have a proven track record of successful FDA submissions.
Lakeside Life Science will define your Regulatory strategy, submit your Presubmission package, design your clinical studies, and prepare your submission packages.