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NorthEast BioLab Agile Bioanalysis Services CRO
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    • Liquid Chromatography Mass Spectrometry
      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
    • Meso Scale Discovery Assay
    • Luminex Multiplex Assay
    • LI-COR Odyssey Assay
    • PK PD Analysis
    • Method Development, Validation, and Transfer
      • Method Validation
      • Method Development
      • Method Transfer
  • Services
    • All Services
    • Pharmacokinetics (PK) Study
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • ADME Studies
    • Toxicology (Tox) Study
      • Dose Formulation Analysis
    • Immunogenicity Testing
    • Biomarker Testing Services
      • Biomarker Assay List
    • Bioequivalence and Bioavailability Studies
    • Bioanalytical Assay
      • Biochemical Assay
      • Mechanism of Action (MOA) Studies
      • Cell-based Assays
      • Cytotoxicity Assay
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    • Bioanalysis
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      • Clinical Trial Sample Management and Storage
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      • Analytical Quantitation
    • Non-GLP Testing
      • Discovery and Research
      • Cosmetic Testing
  • About Us
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      • 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
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  • Request Quote
NorthEast Biolab Agile Bioanalysis Services CRO Request Quote

Expertise

  • All Expertise
    • Liquid Chromatography Mass Spectrometry
      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
      • Meso Scale Discovery Assay
        • Luminex Multiplex Assay
          • LI-COR Odyssey Assay
            • PK PD Analysis
              • Method Development, Validation, and Transfer
                • Method Validation
                • Method Development
                • Method Transfer

              Services

              • All Services
                • Pharmacokinetics (PK) Study
                  • Drug Metabolism and Pharmacokinetics (DMPK)
                  • ADME Studies
                • Toxicology (Tox) Study
                  • Dose Formulation Analysis
                • Immunogenicity Testing
                  • Biomarker Testing Services
                    • Biomarker Assay List
                  • Bioequivalence and Bioavailability Studies
                    • Bioanalytical Assay
                      • Biochemical Assay
                      • Mechanism of Action (MOA) Studies
                      • Cell-based Assays
                      • Cytotoxicity Assay

                    Solutions

                    • All Solutions
                      • Bioanalysis
                        • GLP Laboratory
                          • Clinical CRO
                            • Clinical Trial Sample Management and Storage
                          • Preclinical CRO
                            • Analytical Testing
                              • Analytical Quantitation
                            • Non-GLP Testing
                              • Discovery and Research
                              • Cosmetic Testing

                            About Us

                            • About Us
                              • Overview
                                • Why Us?
                                  • Values
                                    • Leadership
                                      • Process
                                        • Quality and Compliance
                                          • Facility and Equipment
                                            • Therapeutic Areas
                                              • 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
                                                      • News and Events
                                                        • Testimonials
                                                          • Contact Us

                                                            Request Quote

                                                              Contact Us

                                                              • Home
                                                              • Bioanalytical and Bioanalysis Services As Biotech and Pharma CRO

                                                              Top-Notch Bioanalytical Or Bioanalysis CRO Offering Small & Large Molecule Biotech Lab Services

                                                              • Full-Service, USA Based Bioanalytical CRO Lab With 20+ Years Track Record of 500+ Studies And 300+ Methods
                                                              • Founded In Mar 2003 By Ex-Bayer Scientists With Remarkable Hands-On Experience Of Bioanalysis CRO Services
                                                              • Outstanding Lab Partner Trusted By Pioneering Biotech Companies To Rapidly Troubleshoot Their PK, ADA, Or Biomarker Assay
                                                              speak to our scientists

                                                              Learn more about Working with Us.
                                                              Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)
                                                              Bioanalytical and Bioanalysis Services as Biotech & Pharma CRO

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

                                                              VP, Biomarker Development View all Testimonial
                                                              0+ Years Of Bioanalysis
                                                              0+ Small/Large Molecule Studies
                                                              0+ Custom Bioanalytical Methods
                                                              0+ Investigational Drugs
                                                              0+ Biomarker 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.

                                                              What Sponsors Say About Our Services

                                                              VP, Bioanalytical Development

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

                                                              VP, Biomarker Development 

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

                                                              Executive Director, Pharmacokinetics

                                                              We trust NorthEast BioLab to design and execute the most streamlined and 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 Director, 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 truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

                                                              Sr.Director, Bioanalytical Development & QC

                                                              NorthEast BioLab presents a science-based, hands-on, no-frills approach on 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.

                                                              Director, 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 with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.

                                                              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 Take The First Step, Today?

                                                              Explore Our Bioanalytical and Bioanalysis Services As Biotech and Pharma CRO!
                                                              Speak To Our Scientists

                                                              Long-Standing History of Customized Bioanalysis CRO Lab Services

                                                              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

                                                              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 Bioanalytical and Bioanalysis Services As Biotech and Pharma CRO?

                                                              Our Experienced Scientists Are Ready to Help You, Today!
                                                              Speak To Our Scientists

                                                              Explore more about us

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

                                                              Expertise

                                                              • Liquid Chromatography Mass Spectrometry
                                                              • ELISA Method
                                                              • Meso Scale Discovery Assay
                                                              • Luminex Multiplex Assay
                                                              • LI-COR Odyssey Assay
                                                              • PK PD Analysis
                                                              • Method Development Validation and Transfer

                                                              Services

                                                              • Pharmacokinetics (PK) Study
                                                              • Toxicology (Tox) Study
                                                              • Immunogenicity Testing
                                                              • Biomarker Testing Services
                                                              • Bioequivalence and Bioavailability Studies
                                                              • Bioanalytical Assay

                                                              Solutions

                                                              • Bioanalysis
                                                              • GLP Laboratory
                                                              • Clinical CRO
                                                              • Preclinical CRO
                                                              • Analytical Testing
                                                              • Non-GLP Testing

                                                              About Us

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

                                                              Resources

                                                              • Learning Center
                                                              • Blog
                                                              • Case Study
                                                              • News and Events
                                                              • Testimonials
                                                              • Contact Us
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                                                              35 Worth Ave, Hamden, CT 06518

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