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LAKESIDE LIFE SCIENCE

Welcome to Lakeside Life Science, where we are committed to advancing clinical research with precision and expertise. As a full-service in-vitro diagnostic (lVD) clinical research organization, we specialize in designing and managing analytical and clinical validations to ensure successful FDA submissions. Our deep understanding of the science of laboratory test development, the medical application, as well as FDA requirements we empower both traditional manufacturers and LDT providers to navigate the path to clearance or approval for your IVD. Partner with us to ensure your laboratory tests meet the highest standards of compliance and success.

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OUR SERVICES

We have successfully supported FDA clearances and approvals for a diverse array of in vitro diagnostics (IVDs), laboratory-developed tests (LDTs), and companion diagnostics (CDx). Our experience spans critical therapeutic areas, including oncology, infectious diseases, liver disease, and bone metabolic disorders, ensuring that our studies are both scientifically rigorous and strategically aligned with your business goals.

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Partner with Lakeside Life Science to leverage our expertise in clinical and analytical validation, and accelerate the path to market for your diagnostic innovations.

PROJECT AND PRODUCT DEVELOPMENT
ANALYTICAL TESTING
 
CLINICAL STUDIES

 
REGULATORY STRATEGY AND FDA SUBMISSIONS

WHY LAKESIDE?

We have the team, the experience, and the culture.  Learn more >

>200

Analytical protocols released and implemented since 2020

34

Clinical protocols released and 26 implemented

20

IVD related Patents

195

Publications

54

FDA submissions with none denied or withdrawn

INDUSTRIES WE SERVE

Lakeside Life Science can help IVD manufacturers take new technologies to market faster and at lower cost by leveraging our expertise, and industry and clinical network resources.  Clients we serve include:

  • Diagnostic Test Developers and Manufacturers

  • Clinical Laboratories

  • Biotechnology Industry – from start-up to mature

  • Pharma: Companion Diagnostics (CDx)  

  • Other CROs to augment their services 

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ISO 9001:2015 CERTIFIED

Lakeside Life Science is ISO 9001:2015 certified, an internationally recognized standard that ensures that our services meet the needs of our clients through an effective quality management system.

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GET IN TOUCH

Lakeside Life Science is committed to exceeding your needs. Questions, comments, or special requests? We’d love to hear from you, don’t hesitate to reach out today.

171 Daniel Webster Highway, Suite 11
Belmont, NH 03220

603-527-8107

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