Scientific Expertise for Preclinical CRO

Accelerated turnaround
while ensuring superior
quality and results

Learn More...
Bioanalytical, R&D, and Sample Management Services

Bioanalytical, R&D, and
Sample Management Services

Learn More...
Quality and Compliance

Deep scientific expertise
to help navigate pre/clinical

Learn More...

Bioanalysis - Discovery Preclinical and Clinical

Robust bioanalysis to accelerate your drug development process

Comprehensive bioanalytical support is crucial at every stage of drug development, whether it’s discovery, nonclinical research, or clinical development. We provide integrated bioanalytical solutions for small and large molecules, supporting all your research and development needs.
Our experienced scientists and skilled lab staff accurately develop, validate, and apply quantitative bioanalytical methods for your toughest projects. Combining highly specialized laboratory expertise with industry practitioner insights, we help navigate our clients through the complexities of scientific and regulatory requirements.
Clinical Bioanalysis

Our projects typically start at the pre-clinical phase and carry forward into the clinical phase, given the depth of our services and expertise. Clients benefit from our robust bioanalytical methods and data management. Adjacently, we have a spotless history of clinical sample management and kit assembly.Over the past few years, we have provided sample kits to a large number of studies worldwide.

Nonclinical Bioanalysis

Our meticulous scientists develop, validate, and optimize bioanalytical methods to carefully determine drug and metabolite concentrations in plasma, serum, and urine. We are adept at running PK/TK and other similar analysis using HPLC and LC/MS/MS systems. Our “Clients First” philosophy propagates existential vendor collaboration as an investment that helps us learn, stay grounded and be nimble.

Discovery Bioanalysis

Our veteran scientific team develops and fine-tunes research-grade assays (RGAs) to balance predefined analysis quality with quick data turnaround. We have extensive experience in analyzing routine matrices such as blood, serum, plasma and urine, and non-routine matrices such as various tissues, cerebrospinal fluid (CSF) etc. We add substantial value by driving a clear strategic focus through the risk-benefit of “fit-for-purpose”.

What Our Clients Say

The projects ranged from method validation and stability studies, cross-validation of other external labs, support for investigator sponsored studies, Clinical Phase I to Phase IV studies (including pivotal BE studies). Our last major study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers were to be analyzed within a very short time frame. This study – and all other studies – were done according to a very high quality and reporting standard and with a high responsiveness. We have audited the Lab in 2004 by our BHC GLP QAU and in 2006 by a BHC GLP trained bioanalytical expert, in both cases without major findings.

Bernhard Beckermann, Ph.D., Bayer Schering AG, Germany

We have worked with NorthEast Biolab on several programs and have found them to be professional, collaborative and responsive. As a small company, our vendors are key members of our project teams. The scientists at NorthEast Biolab are technical experts, who produce high quality data, on-time and on-budget. They also provided critical insight into data analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend NothEast Biolab and look forward to working with them in the future.

Marcia Dougan Moore, M.P.H, Arvinas, Inc.

I have worked with a number of companies (large and small) over the years and NorthEast Biolab is by far the most responsive and thorough service provider. In an industry where a vast majority of businesses establish practices that remain rigid, NorthEast Biolab works closely with the client to provide the most efficient and cost-effective approach to getting the job done. The integrity of the scientific staff is as refreshing as their willingness to provide ingenious scientific input and high-quality data. They truly go that extra mile to make the collaborations successful and I will continue to enjoy very productive interactions with them in the future.

Tom Stephen, Ph.D., CGI Pharmaceuticals, Inc.