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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
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    • LI-COR Odyssey Assay
    • PK PD Analysis
    • Method Development, Validation, and Transfer
      • Method Validation
      • Method Development
      • Method Transfer
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    • 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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      • 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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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
                                                              • Ensuring FDA Compliance And Adherence To ICH Quality Guidelines

                                                              GLP/GCLP Compliant, FDA Audited, DEA & CT Schedule II-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

                                                              Learn more about Working with Us.
                                                              Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)
                                                              Quality and Compliance

                                                              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 Methods
                                                              0+ Investigational Drugs
                                                              0+ Biomarker 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.

                                                              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 FDA Compliant And ICH Quality Guideline Adherent Bioanalytical Lab!
                                                              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

                                                              • 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.

                                                                View All Expertise
                                                              • 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

                                                              Questions On Our FDA Compliant And ICH Quality Guideline Adherent Bioanalytical Lab?

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                                                              Explore more about us

                                                              • Overview
                                                              • Why Us?
                                                              • Values
                                                              • Leadership
                                                              • Process
                                                              • 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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