NorthEast BioLab Logo | Advanced Bioanalytical Services Lab Agile Bioanalytical Services CRO
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    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
    • Menu IconELISA Assay
      • Menu IconLuminex Multiplex Assay
    • Menu IconFlow Cytometry
    • Menu IconqPCR Analysis, ddPCR Assay
    • Menu IconWestern Blot, In Cell Western
  • Services
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    • Menu IconPharmacokinetics (PK) Study
      • Menu IconToxicology (Tox) Study
      • Menu IconDose Formulation Analysis
      • Menu IconPK PD Analysis
      • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
      • Menu IconADME Studies
      • Menu IconBioequivalence and Bioavailability Studies
    • Menu IconADA Assay, Neutralizing Antibody Assay
    • Menu IconMultiplex Cytokine Assay
    • Menu IconBiomarker Assay
      • Menu IconBiomarker Assay List
    • Menu IconCell-Based Assay
      • Menu IconMechanism of Action (MOA) Studies
      • Menu IconCytotoxicity Assay
      • Menu IconBiochemical Assay
    • Menu IconBioanalytical Assay Validation
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      • Menu IconMethod Validation
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      • Business Development Associate
      • Sr. Scientist – Cell Based Assay
      • GLP Quality Assurance Manager
      • Sr. Scientist, ELISA Immunoassay Bioanalysis
      • Sr. Scientist, LC-MS/MS Bioanalysis
      • Associate Scientist, Central Laboratory Services
      • Sr. Scientist - Pharmacokinetics (PK)
      • Content Manager, Scientific and Regulatory Writing
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Expertise

  • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
      • Menu IconELISA Assay
        • Menu IconLuminex Multiplex Assay
      • Menu IconFlow Cytometry
        • Menu IconqPCR Analysis, ddPCR Assay
          • Menu IconWestern Blot, In Cell Western

            Services

            • Menu IconAll Services
              • Menu IconPharmacokinetics (PK) Study
                • Menu IconToxicology (Tox) Study
                • Menu IconDose Formulation Analysis
                • Menu IconPK PD Analysis
                • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
                • Menu IconADME Studies
                • Menu IconBioequivalence and Bioavailability Studies
              • Menu IconADA Assay, Neutralizing Antibody Assay
                • Menu IconMultiplex Cytokine Assay
                  • Menu IconBiomarker Assay
                    • Menu IconBiomarker Assay List
                  • Menu IconCell-Based Assay
                    • Menu IconMechanism of Action (MOA) Studies
                    • Menu IconCytotoxicity Assay
                    • Menu IconBiochemical Assay
                  • Menu IconBioanalytical Assay Validation

                    Solutions

                    • Menu IconAll Solutions
                      • Menu IconClinical CRO
                        • Menu IconCentral Lab Services
                        • Menu IconPBMC Services
                      • Menu IconGLP Laboratory
                        • Menu IconBioanalysis
                        • Menu IconNon-GLP Testing
                      • Menu IconPreclinical CRO
                        • Menu IconMethod Development, Validation, And Transfer
                          • Menu IconMethod Validation
                          • Menu IconMethod Development
                          • Menu IconMethod Transfer
                        • Menu IconAnalytical Testing
                          • Menu IconDiscovery Screening Services
                          • Menu IconAnalytical Quantitation
                          • Menu IconCosmetic Testing

                        About Us

                        • Menu IconAbout Us
                          • Menu IconOverview
                            • Menu IconLeadership
                              • Menu IconFacility and Equipment
                                • Menu IconQuality and Compliance
                                  • Menu IconTherapeutic Areas
                                    • Menu IconWhy Us?
                                      • Menu IconValues
                                        • Menu IconProcess
                                          • Menu IconPartners
                                            • Menu IconCareers
                                              • Menu IconBusiness Development Associate
                                              • Menu IconSr. Scientist – Cell Based Assay
                                              • Menu IconGLP Quality Assurance Manager
                                              • Menu IconSr. Scientist, ELISA Immunoassay Bioanalysis
                                              • Menu IconSr. Scientist, LC-MS/MS Bioanalysis
                                              • Menu IconAssociate Scientist, Central Laboratory Services
                                              • Menu IconSr. Scientist - Pharmacokinetics (PK)
                                              • Menu IconContent Manager, Scientific and Regulatory Writing

                                            Resources

                                            • Menu IconLearning Center
                                              • Menu IconBlog
                                                • Menu IconCase Study
                                                  • Menu IconVideo Brochures
                                                    • Menu IconNews and Events
                                                      • Menu IconTestimonials
                                                        • Menu IconContact Us

                                                          Request Quote

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                                                            • Home
                                                            • Ensuring FDA Compliance And Adherence To ICH Quality Guidelines

                                                            GLP/GCLP Compliant, FDA Audited, DEA & CT Schedule I-IV Approved, Watson LIMS Enabled Lab

                                                            • Standalone Quality Assurance Unit (QAU) Ensures Strict Adherence To FDA & ICH Quality Compliance Plus Bioanalysis SOPs
                                                            • Treat Sample Integrity As One Of The Most Important Aspects Of Bioanalysis And Monitor Full Chain Of Custody During Storage
                                                            • Regular Compliance Training On The Job And Through Scheduled Sessions On General Lab Practices, Procedures, Sample Handling, Documentation, Etc.

                                                            speak to our scientists

                                                            Regulated And Inspected By:

                                                            Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)Clinical Laboratory Improvement Amendments (CLIA)International Orgaization for Standardization (ISO)
                                                            GLP/GCLP Compliant | NorthEast BioLab

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

                                                            SVP Quality & Compliance, Biotech

                                                            View all Testimonial
                                                            0+ Years Of Bioanalysis
                                                            0+ Small/Large Molecule Studies
                                                            0+ Custom Bioanalytical Assays
                                                            0+ Investigational Drugs
                                                            0+ Biomarker & Cytokine Assays

                                                            Choose A GLP And GCP Compliant, FDA Audited Bioanalytical Lab Services CRO

                                                            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. Furthermore, QAU seeks to constantly improve lab operation based on any audit feedback from regulatory authorities or sponsor inspections.

                                                            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.

                                                            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 the most responsive and thorough bioanalysis lab services CRO.”

                                                            User Vector
                                                            VP, Biomarker Development 

                                                            NorthEast BioLab is a responsive, collaborative, and reliable partner

                                                            User Vector
                                                            Executive Director, Pharmacokinetics

                                                            We trust NorthEast BioLab to design and execute streamlined, 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 goes the extra mile. We look forward to more meaningful collaborations.”

                                                            User Vector
                                                            Sr. Dir., Bioanalytical Development & QC

                                                            NorthEast BioLab offers a science-based, hands-on approach to 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, was completed with top quality and reporting standard with incredible responsiveness.

                                                            User Vector
                                                            VP, Development Operations

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

                                                            What Do You Need to Know About FDA Compliance and ICH Quality Review?

                                                            Speak To Our Scientists
                                                            • NorthEast BioLab Jobs: Learn And Grow With A Diligent Team Of Bioanalytical Experts!

                                                              Join, NorthEast BioLab, a bioanalytical CRO lab based in New Haven, CT. Our team partners with a broad array of biotechnology and pharmaceutical sponsors. We have multiple analytical chemistry, biochemistry, quality assurance, and project management job openings at various experience levels for qualified candidates.

                                                              Meaningful exposure to various aspects of bioanalysis at our company can fast-track your drug research and development career. During studies with us, you could reasonably expect to master the crucial skills for a successful biotech lab career, including independent i) Development/Transfer Of Robust Bioanalytical Methods, and ii) Performance Of High-Quality And Timely Bioanalysis.

                                                              Learn More About Career

                                                            Registered And Inspected By Various Regulatory Agencies

                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
                                                            • Food and Drug Administration (FDA | NorthEast BioLab
                                                            • clia
                                                            • United States Drug Enforcement Administration | NorthEast BioLab
                                                            • Department of Consumer Protection | NorthEast BioLab
                                                            • Explore Our Services And Expertise

                                                              NorthEast BioLab has distinct track record of advancing your research and GLP bioanalysis services from drug discovery to development and beyond.

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                                                            • Learn More About Drug Development And Bioanalysis

                                                              Get access to the latest news on Drug Discovery and Development process. Here you will find all the necessary information to bring your analytical research to success.

                                                              View All Blogs

                                                            How Our Team Can Help You Achieve FDA Compliance and ICH Quality Standards?

                                                            SPEAK TO OUR SCIENTISTS

                                                            Download Today Your Free Copy Of

                                                            “Top 7 Hidden Pitfalls to Your Bioanalytical Milestones"

                                                            Explore more about us

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

                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Expertise

                                                            Expertise

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

                                                            Services

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Multiplex Cytokine Assay
                                                            • 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
                                                            sales@nebiolab.comFollow Up On Email
                                                            (203) 361 3780Follow Up On Phone

                                                            35 Worth Ave, Hamden, CT 06518

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