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      • GLP Quality Assurance Manager, Bioanalytical Lab
      • Sr. Scientist, ELISA Immunoassay Bioanalysis
      • Sr. Scientist, LC-MS/MS Bioanalysis – Hamden, CT, USA
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Expertise

  • All Expertise
    • Mass Spectrometry (LC-MS)
      • Mass Spectrometry Services
      • HPLC Testing Services
    • Meso Scale Discovery Assay
      • ELISA Assay
        • Luminex Multiplex Assay
      • qPCR Analysis, ddPCR Assay
        • Western Blot, In Cell Western

          Services

          • All Services
            • Pharmacokinetics (PK) Study
              • Toxicology (Tox) Study
              • Dose Formulation Analysis
              • PK PD Analysis
              • Drug Metabolism and Pharmacokinetics (DMPK)
              • ADME Studies
              • Bioequivalence and Bioavailability Studies
            • ADA Assay, Neutralizing Antibody Assay
              • Cytokine Analysis, Biomarker Assay
                • Biomarker Assay List
              • Cell-Based Assays
                • Mechanism of Action (MOA) Studies
                • Cytotoxicity Assay
                • Biochemical Assay
              • Bioanalytical Assay Validation

                Solutions

                • All Solutions
                  • Clinical CRO
                    • Central Lab Services
                  • GLP Laboratory
                    • Bioanalysis
                    • Non-GLP Testing
                  • Preclinical CRO
                    • Method Development, Validation, And Transfer
                      • Method Validation
                      • Method Development
                      • Method Transfer
                    • Analytical Testing
                      • Discovery and Research
                      • Analytical Quantitation
                      • Cosmetic Testing

                    About Us

                    • About Us
                      • Overview
                        • Leadership
                          • Facility and Equipment
                            • Quality and Compliance
                              • Therapeutic Areas
                                • Why Us?
                                  • Values
                                    • Process
                                      • Partners
                                        • Careers
                                          • GLP Quality Assurance Manager, Bioanalytical Lab
                                          • Sr. Scientist, ELISA Immunoassay Bioanalysis
                                          • Sr. Scientist, LC-MS/MS Bioanalysis – Hamden, CT, USA
                                          • Associate Scientist, Central Laboratory Services
                                          • Sr. Scientist - Pharmacokinetics (PK) Studies
                                          • Content Manager, Scientific and Regulatory Writing

                                        Resources

                                        • Learning Center
                                          • Blog
                                            • Case Study
                                              • Video Brochures
                                                • News and Events
                                                  • Testimonials
                                                    • Contact Us

                                                      Request Quote

                                                        Contact Us

                                                        • Home
                                                        • CRO Service, Pharma CRO, BioTech CRO, Bioanalytical CRO

                                                        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

                                                        speak to our scientists

                                                        Regulated And Inspected By:

                                                        Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)
                                                        Female Scientist Performing Bioanalytical and Bioanalysis CRO Services | NorthEast BioLab

                                                        We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

                                                        VP, Biomarker Development View all Testimonial
                                                        Bioanalytical CRO Service | NorthEast BioLab
                                                        0+ Years Of Bioanalysis
                                                        0+ Small/Large Molecule Studies
                                                        0+ Custom Bioanalytical Assays
                                                        0+ Investigational Drugs
                                                        0+ 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. 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
                                                        • 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
                                                        • Full service, GLP and GCP compliant, FDA audited, DEA Schedule II-V approved bioanalytical laboratory specializing in bioanalysis of pharma, generics, biologics, vaccines, etc.
                                                        Female Scientist Performing Bioanalytical and Bioanalysis CRO Services | NorthEast BioLab

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

                                                        Connect With Us For A Reference Call With Them!

                                                        User Vector
                                                        VP, Bioanalytical Development

                                                        NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.

                                                        User Vector
                                                        VP, Biomarker Development 

                                                        We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

                                                        User Vector
                                                        Executive Director, Pharmacokinetics

                                                        We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.

                                                        User Vector
                                                        President & CSO, Biotech

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

                                                        User Vector
                                                        Sr. Associate Dir., Clinical Trials

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

                                                        User Vector
                                                        Co-Founder, Biotech & University PI

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

                                                        User Vector
                                                        VP, PK PD Analysis

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

                                                        User Vector
                                                        Head, Bioanalytical Development

                                                        NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

                                                        User Vector
                                                        Sr. Dir., Bioanalytical Development & QC

                                                        NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.

                                                        User Vector
                                                        SVP Quality & Compliance, Biotech

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

                                                        User Vector
                                                        Director, PK

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

                                                        User Vector
                                                        VP, Head of Clinical Operations

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

                                                        User Vector
                                                        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.

                                                        User Vector
                                                        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.

                                                        User Vector
                                                        Head, PK

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

                                                        User Vector
                                                        VP, Development Operations

                                                        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.

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

                                                        Speak To Our Scientists
                                                        Bioanlaytical CRO Service As Your Preferred Pharma CRO Or BioTech CRO | NorthEast BioLab

                                                        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. 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 CRO pharma 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

                                                        • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
                                                        • Food and Drug Administration (FDA | NorthEast BioLab
                                                        • United States Drug Enforcement Administration | NorthEast BioLab
                                                        • Department of Consumer Protection | NorthEast BioLab

                                                        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?

                                                        Speak To Our Scientists

                                                        Explore more about us

                                                        • Leadership
                                                        • Facility and Equipment
                                                        • Quality and Compliance
                                                        • Therapeutic Areas
                                                        • Why Us?
                                                        • Values
                                                        • Process
                                                        • Partners
                                                        • Careers

                                                        Expertise

                                                        Expertise

                                                        • Mass Spectrometry (LC-MS)
                                                        • Meso Scale Discovery Assay
                                                        • ELISA Assay
                                                        • qPCR Analysis, ddPCR Assay
                                                        • Western Blot, In Cell Western

                                                        Services

                                                        Services

                                                        • Pharmacokinetics (PK) Study
                                                        • ADA Assay, Neutralizing Antibody Assay
                                                        • Cytokine Analysis, Biomarker Assay
                                                        • Cell-Based Assay
                                                        • Bioanalytical Assay Validation

                                                        Solutions

                                                        Solutions

                                                        • Clinical CRO
                                                        • GLP Laboratory
                                                        • Preclinical CRO
                                                        • Method Development, Validation, And Transfer
                                                        • Analytical Testing

                                                        About Us

                                                        About Us

                                                        • Overview
                                                        • Leadership
                                                        • Facility and Equipment
                                                        • Quality and Compliance
                                                        • Therapeutic Areas
                                                        • Why Us?
                                                        • Values
                                                        • Process
                                                        • Partners
                                                        • Careers

                                                        Resources

                                                        Resources

                                                        • Learning Center
                                                        • Blog
                                                        • Case Study
                                                        • Video Brochures
                                                        • News and Events
                                                        • Testimonials
                                                        • Contact Us
                                                        NorthEast BioLab Logo Agile Bioanalytical Services CRO

                                                        35 Worth Ave, Hamden, CT 06518

                                                        sales@nebiolab.comFollow Up On Email
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                                                        • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
                                                        • Food and Drug Administration (FDA | NorthEast BioLab
                                                        • United States Drug Enforcement Administration | NorthEast BioLab
                                                        • Department of Consumer Protection | NorthEast BioLab
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