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Top-Notch Bioanalytical CRO Service As Preferred Pharma CRO Or Biotech CRO For 20+ Years

Full-Service, USA Based Bioanalytical CRO Lab With Track Record of 600+ Studies And 300+ Custom Methods
Founded In Mar 2003 By Ex-Bayer Scientists With Remarkable Hands-On Experience Of Bioanalytical CRO Service
Outstanding CRO Services Trusted By Pioneering BioTech For PK, Immunogenicity, Cytokine, Or Cell Based Assay

Regulated And Inspected By:

20+ Years Of Bioanalysis

700+ Small/Large Molecule Studies

450+ Custom Bioanalytical Assays

200+ Investigational Drugs

1,000+ Biomarker & Cytokine Assays

Mission Driven Scientists Offering Bioanalytical and Bioanalysis CRO Services

NorthEast BioLab, has 20+ years of experience in offering bioanalytical analysis CRO services for quantitating drugs, metabolites, and biomarkers, as well as clinical trial kitting and biosample storage. We take pride in offering tailored bioanalytical analysis CRO services that support every stage of drug development, ensuring both precision and regulatory compliance. As a Bioanalytical CRO Lab, we are dedicated to ensuring precision and compliance across all phases of drug development. Our mission-driven team of veteran scientists has an excellent track record of providing rapid and high-quality drug development, GLP, and clinical bioanalytical services. Thus, you can rely on our team of seasoned professionals and accomplished scientists to always deliver accurate results.

Company Overview:

Entrepreneurial and mission-driven Biotech CRO in New Haven, CT, aiming to realize the full potential of our dedicated scientists
Completed 500+ preclinical and clinical bioanalysis studies, where sponsors included data in Investigational New Drug (IND), New Drug Application (NDA), Generics Application (ANDA), and Biologic License Application (BLA) filings
We offer bioanalytical analysis CRO services with outstanding experience in regulated PK Study and Tox (TK) Safety Testing using LC-MS/MS or ELISA immunoassay bioanalytics.
Other bioanalytical CRO lab capabilities include Biomarker Testing, Immunogenicity Testing, Cell-based Assay, Cytotoxicity Assay, Biochemical Assay, and Mechanism of Action (MoA) Studies
We are a full-service, GLP and GCP compliant, FDA audited, DEA Schedule II-V approved bioanalytical CRO Lab, specializing in the bioanalysis of pharma, generics, biologics, vaccines, etc.

Sponsors Love Our One-Stop Bioanlaytical Laboratory Services For Top Quality And Industry Leading Turnaround

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VP, Bioanalytical Development

“NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.”

VP, Biomarker Development

NorthEast BioLab is a responsive, collaborative, and reliable partner

Executive Director, Pharmacokinetics

We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects

President & CSO, Biotech

We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data

Sr. Associate Dir., Clinical Trials

We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

Co-Founder, Biotech & University PI

NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism

VP, PK PD Analysis

NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

Head, Bioanalytical Development

“NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”

Sr. Dir., Bioanalytical Development & QC

NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms

SVP Quality & Compliance, Biotech

We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.

Director, PK

We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

VP, Head of Clinical Operations

Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

Executive Director, Drug Research

NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.

Dir., Bioequivalence Testing

Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

Head, PK

This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.

VP, Development Operations

NorthEast BioLab’s scientists deliver high-quality data on time and within budget

Ready To Tackle Your CRO Service Need With Our Pharma And Biotech CRO?

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Long-Standing History of Customized Bioanlaytical CRO Service As Your Preferred Pharma CRO Or BioTech CRO

NorthEast Biolab has a successful history as an independent CRO Lab services provider in the consolidating world of outsourced pharma research and drug development. We are continually exploring opportunities for new research projects, preclinical studies, and clinical trials. Our core objective remains to provide you with high-quality, actionable data within the quoted budget and expected timelines. In addition to our bioanalytical analysis CRO services, we optimize the combined expertise of our veteran and your in-house scientific team to bring success to our partner pharma and biotech companies. Thus, our decades of acquired experience and applied knowledge can help you forge seamless operations. As a leading Pharma CRO company, we deliver accurate results for your processes time and again. It is a partnership, thriving on trust and transparency. To that end, we have established integrity, respect, and excellence as the cornerstones of our organization. Furthermore, we are open to and thoroughly enjoy our partnerships with other CRO companies to support your drug research and development.

Background & History:

An ambitious group of healthcare investors and scientists brought together by a shared passion for high-quality and innovative drug development and research
In our quest to facilitate superior treatments, we learned that it takes deep-rooted partnerships to develop/commercialize medicines for life-threatening diseases
Driven by this principle, we founded NorthEast BioAnalytical Laboratories (NorthEast BioLab) – a boutique clinical research organization (CRO) – in 2003
Henceforth, we have stayed focused on providing tailor-made bioanalysis CRO solutions to biotech and pharma companies
Seek fulfillment in providing clients with flexibility and versatility with excellent standards of quality service for each project
High quality plays an instrumental role in drug development programs – especially as our clients are usually looking to expedite drug development with lower overall costs

Registered And Inspected By Various Regulatory Agencies

Join Our Diverse CRO Roster Of Top Biotech and Pharma Companies

We have maintained a thriving CRO company due to our diverse client base. From emerging biotech to top pharma companies, we serve the full spectrum of the industry with our drug discovery and development solutions. Furthermore, we appreciate broadening our horizons to welcome an even wider variety of clients to our expanding team, including several personal care and food testing companies. We have built our reputation as a service-based small business partnering with top biotech and pharma companies. We frequently collaborate with notable academic labs at Brown, Dana Farber, Columbia, Duke, MD Anderson, Sarah Cannon, Sloan Kettering, Moffitt, UChicago, UCSF, Yale, etc. We take on each of your studies as a passion project where our scientists and expert team members strive to achieve the best possible outcome for you.

Customer Mix:

- Emerging Mid / Small Biotech (~70%)

– Diverse therapeutic areas (Oncology, Cardiovascular, Rare Diseases, etc.)
– Small and large molecules (biologics, peptides, nucleic acids)

- Others (~30%)

– Fortune 100 pharma and biopharma
– Research institutes, universities, and clinical trial networks
– CRO partners (preclinical, clinical, and research affiliates)

We, at NorthEast BioLab, take pride in the fact that the diversity of our client base matches the diversity of our staff. Our team consists of industry leaders and subject matter experts within the field of pharmaceutical/biotech R&D and bioanalysis. We enjoy bringing the best scientific, operational, and clinical experience to each project. Our team understands that it takes considerable time, effort, and resources to successfully initiate, manage, monitor, and complete drug development studies. Therefore, our CRO lab team of experts will put our decades of collective experience and expertise to work for you. You can rest assured that we will enthusiastically commit our time, energy, effort, and resources to your program.

Contact us so we can determine the business fit and discuss our partnership. From our end, we will focus on how our team here at NorthEast Biolab can help you and your organization.

Questions On Our CRO Service As Reliable Biotech and Pharma CRO?

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Related FAQs

What is a Bioanalytical CRO?

A Bioanalytical CRO (Contract Research Organization) provides specialized laboratory services such as bioanalytical testing, method development, and validation for pharmaceutical and biotechnology companies. They play a crucial role in drug development by ensuring the safety and efficacy of new drug candidates.

What are the benefits of partnering with a Bioanalytical CRO?

Partnering with a Bioanalytical CRO like ours ensures access to state-of-the-art laboratory facilities, expert scientific teams, and streamlined processes. This partnership can accelerate drug development timelines, reduce costs, and ensure regulatory compliance.

What services do we offer as a Bioanalytical CRO?

We offer a comprehensive range of bioanalytical services, including method development and validation, pharmacokinetic and toxicokinetic studies, biomarker analysis, and more. Our state-of-the-art Bioanalytical CRO Lab supports various stages of drug development.

How does our CRO support biotech companies?

As a leading Biotech CRO, we provide tailored bioanalytical and regulatory support to emerging biotechnology companies. Our services help optimize drug discovery and development processes, ensuring successful progression through clinical trials.

Why choose our Pharma CRO services?

With over 20 years of experience, we are a preferred Pharma CRO for many pharmaceutical companies. Our expertise in bioanalytical analysis, compliance with regulatory standards, and a proven track record of successful partnerships make us an ideal choice for pharmaceutical research and development needs.

What distinguishes our Bioanalytical CRO Lab from others?

Our Bioanalytical CRO Lab is equipped with advanced technology and staffed by experienced scientists. We offer precise and reliable bioanalytical analysis CRO services, adhering to stringent quality control measures to meet the highest industry standards.

How can CRO services accelerate drug development in the biotech and pharmaceutical industries?

CRO services provide specialized knowledge and infrastructure, enabling biotech and pharmaceutical companies to focus on core competencies. By outsourcing bioanalytical tasks, companies can achieve faster turnaround times, efficient resource utilization, and improved regulatory compliance, accelerating the drug development process.

What types of bioanalytical analysis do we specialize in?

We specialize in a variety of bioanalytical analyses, including but not limited to, small and large molecule bioanalysis, biomarker analysis, immunogenicity testing, and pharmacokinetic studies. Our services cater to both early and late-stage drug development.

Can we support both GLP and non-GLP bioanalytical studies?

Yes, we offer both GLP (Good Laboratory Practice) and non-GLP bioanalytical services. This flexibility allows us to support different stages of drug development, from early discovery through to regulatory submission.

What is flow cytometry used for?

Flow cytometry is a laboratory-based technique that helps to analyze cells or cell components in a sample (suspended in a fluid) by measuring cell count and determining their physical and chemical characteristics. It finds extensive application as a research and diagnostic tool for diseases.

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