Deep scientific expertise
to help navigate pre/clinical
challenges

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Comprehensive
Bioanalytical, R&D, and
Sample Management Services

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Accelerated turnaround
while ensuring superior
quality and results

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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.
Discovery Bioanalysis
(Non-GLP)

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”.

Nonclinical Bioanalysis
(GLP)

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.

Clinical Bioanalysis
(GLP)

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.

Critical solutions for your drug development program

Enhanced speed and accuracy while ensuring high quality result

As your trusted bioanalytical partner, we aim to provide high quality, end-to-end solutions, and efficiently accelerate your drug development process from target identification through clinical development and beyond.
Our periodically inspected, GLP compliant facilities strictly adhere to the latest guidelines from domestic and international regulatory bodies and organizations, such as FDA, CDC, OECD and EMA.
Bioanalytical and Pharmacokinetic Analyses
  • Method feasibility, development, transfer, and validation
  • Drug and metabolite analysis in biological fluids
  • Dose range finding
  • Bioavailability and drug metabolism
  • Bioequivalence
  • Protein binding determination
  • Safety assessment through Toxicokinetic (TK) and drug viability
  • Immunogenicity through i) screening, ii) confirmation and iii) titter based quantification
  • Drug-drug interaction
  • Chiral separations
  • Tissue analysis
  • Pharmacokinetic evaluation and reporting (WinNonlin)
Drug Discovery and Research
  • Target identification and validation
    1. Small interfering RNA (siRNA) and gain-of-function studies
    2. Translational medicine analysis
  • Assay development
    1. Stable mammalian cell line generation
    2. Biochemical assays with expression and purification of proteins
    3. Primary cell systems
    4. Genetic analysis, including cloning, mutation etc.
  • Lead optimization
    1. “Mechanism of action”, including pathway identification
    2. Compound profiling and pharmacology – early efficacy, safety, and toxicity
    3. Cell proliferation assay
Clinical Sample Management and Storage
  • Sample collection management and support
    1. Pharmacokinetic
    2. Biomarker
    3. FFPE Tumors
  • Sample collection kit supply to clinical sites
    1. Collection manuals
    2. All supplies to collect, store and ship
    3. Handling instructions
    4. Logistics oversight
  • Direct collaboration and regular status update with clinical sites
  • Long-term sample storage with 24/7 continuous temperature monitoring
    1. -70°C, -20°C, 4ºC, ambient nitrogen chamber
We are an ambitious group of healthcare investors and scientists brought together by our shared passion for high-quality and innovative drug development and research. In our quest, we have learned that it takes deep-rooted partnerships within the scientific community to develop and commercialize superior treatments for life-threatening diseases. Driven by this fundamental, we founded North East Bioanalytical Laboratories (NorthEast BioLab ) – a boutique clinical research organization (CRO) in 2003. Ever since we have been focused on providing tailored research and development solutions to biotech and pharma companies. Based in Connecticut, we are an entrepreneurial and mission-driven CRO aiming to realize the full potential of our dedicated scientists and analytical chemists.
We streamline our projects for efficient delivery at your terms.
Symbiotic Business Partnership

Systematically accelerate and focus your priorities.

NorthEast BioLab ’sclient-centric approach creates lasting partnerships that help overcome challenges and advance together towards bringing new drugs to market. Our experience in helping multiple clients along a similar pathway translates into accomplishing all this with attractive resource and cost efficiencies for you. Furthermore, our collaborative mind-set enables working in unison with your internal team and other vendors towards our shared common goals.

Distinguished Service Offering

Expect collaborative onboarding, rollout, and delivery.

We are committed to 100% process transparency with all our clients. We inculcate collaboration through disintermediated and ongoing communication of clients with our frontline lab analysts and managers. We understand the dynamic and evolving nature of our work and balance the scales in your favor through our promise of enhanced flexibility and quick turnaround. That said, we have uncompromising scientific ethics and dedication to high quality facilitated by our staff’s integrity, passion, teamwork, and our continually evolving Quality Systems.

Drug Development Expertise

Navigate your drug candidates to the clinical phase.

The success of your drug development program is our primary focus. We will help you with target identification and validation, assay development, lead optimization, preclinical development, all the way into clinical trials and market. Our integrated bioanalytical services are designed to optimize your cost and resources, leveraging our scientific expertise, operational excellence and latest knowledge of the regulatory environment.

Our business values broadly stem from the following four pillars:
Partnership with
Clients

We firmly believe in treating our customers with utmost respect, and take full responsibility and ownership of delivering flawlessly on our promises. We achieve this by fostering a deep sense of care among our employees for what our clients are trying to accomplish. “Say what we mean, and mean what we say.”

Impact on
Society

We are a positive and optimistic enterprise that’s intrinsically motivated to contribute disproportionately higher towards fighting life-limiting diseases, such as cancer. We aim to fulfill this commitment towards our very own families and the broader humanity by helping discover the right treatment.

Quest
for Knowledge

Ultimately, we are driven by our employees’ intellectual curiosity. The inner scientist in each of our analytical chemists is constantly fueled by daily successes / failures during experimentation. Our emphasis on the need to become practice area experts helps ignite innovation.

Swiftness
of small business

Collectively, we look at our size positively as compared to multi-billion dollar CROs out there. We pride ourselves on our ability to be nimble and offer clients a tailor-made experience.

 

“Building a new kind of drug development and research company – created in, of and for the 21st century…”

Vipin Agarwal
CEO and President 30+ years’ experience MBA, Rensselaer Polytechnic, New York

 

“Finding fulfillment in the never-ending pursuit of putting good science to work for all…”

Ronald Mays
Laboratory Director 20+ years’ experience B.S.

 

“Working with great teams to help find cure for the most menacing diseases of our generation…”

 

Ajay Bhargava
VP, Oncology 30+ years’ experience Ph.D., Indian Institute of Science (IISc)]

 

“I’m driven to build lasting and rewarding partnerships to bring more joy to our customers’ and employees’ lives…”

Abhay Pandey
VP, Business Development ~10+ years’ experience MBA, Duke University, Fuqua School of Business
Our scientists have significant exposure to all major therapeutic areas. From a bioanalytical viewpoint, we see ourselves as therapeutic area agnostic,as we routinely analyze drug samples from any of them with minimal adjustments to our equipment and processes. That said, we are increasingly focusing more on oncology to align our interests with the demands of our current and prospective clients. Within oncology, we see a tremendous opportunity for innovation and efficiency in the drug development process,leading to higher R&D productivity and ultimately increased access to life-saving / prolonging drugs for millions of patients. To that end, our team has excellent name recognition among all premier Oncology centers in the US including, Dana Farber, MD Anderson, Sarah Cannon, Sloan Kettering, Moffitt Cancer Center, and Yale Cancer Center etc.
Over 15+ years of our existence, we have been fortunate to cross path with many organizations that share our fiber of business values even as they operate across varying stages of drug development and research. Here’s a select mention of a few of our partners that collaborate extensively with us.
We judiciously invest in technology and infrastructure to meet/exceed our promised business standards. Our laboratory facility spans 8,000+ sq. ft. and has substantial room for expansion. We have several validated LC/MS/MS with Analyst®and HPLC with TotalChrom®systems for data collection, processing, and reporting. Our LC/MS/MS systems are set up with dual column capability and micro HPLC gradient systems. All HPLC systems are equipped with Ultraviolet and Fluorometric detectors. Other equipment include Luminometers and Fluorescence plate readers, SpectraMax plate readers, Bio-Rad Bio-Plex system, and BioTek plate washers. Supporting instrumentation include pH meters, Balances, Centrifuges, and turbovaps. All equipment/instruments are properly designed and routinely maintained. Our facility is access and temperature controlled with 24x7 monitoring and is backed up by power generators. We have a secure and redundant IT Infrastructure.

Our laboratory teams stay abreast with the latest regulatory requirements, guidance, and industry expectations. We continually optimize study workflows to maximize efficiency with desired compliance.

Our scientists fully validate bioanalytical methods for your studies and thoroughly assess analyte stability. Sample integrity is the most important aspect of the process and we monitor full chain of custody for sample storage conditions. We conduct end-to-end experimentation and report summary results according to our Standard Operating Procedures (SOPs). Our dedicated Quality Assurance Unit carefully ensures strict compliance with the SOPs and regulatory requirements.

Our audit history with regulatory authorities and client inspections is spotless, with the most recent FDA audit completed successfully as early as 2016. All our employees are routinely trained in regulatory compliance (FDA: GLP, GCP), safety (CDC, OSHA), waste management (EPA), patient privacy (HIPAA), HR focused policies, and additional areas as needed.

In our experience, this continual emphasis on the highest quality translates to reliable and reproducible bioanalytical data for our clients.

Join us in bringing lifesaving drugs to market

Let’s learn and grow together!

NorthEast BioLab is based in the New Haven, CT, and partners with a broad array of pharmaceutical and biotechnology clients. We research small and large molecules and conduct bioanalytical analyses on drugs in early discovery phases through clinical trials and post-approval studies.
You will join a talented, dynamic, and flexible team that’s deploying state of the art laboratory techniques to enable our clients to bring drugs to markets faster. We will provide you ample opportunity to lead projects and thereby deepen your subject matter expertise.
We are currently undergoing strong growth and rapidly expanding operations. Employee fit and talent are our primary hiring criteria. If you see NorthEast BioLab as a potential employer, please apply to the specific opening or/and contact us directly.

Dried Blood Spot Analysis

Background

Dried blood spot (DBS) analysis has been practiced for ~100 years[1], but has started gaining traction as an alternate to traditional assays only this decade. Human / Animal blood is spotted on prepared filter cards, the cards are air dried, stored in airtight bags, and shipped under administered humidity and temperature levels[2]. For bioanalytical analysis, we punch tiny discs out of ...

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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.