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NorthEast BioLab Agile Bioanalysis Services CRO
  • Expertise
    • Liquid Chromatography Mass Spectrometry
      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
    • MSD Assay
    • Luminex Multiplex Assay
    • LI-COR Odyssey Assay
    • PK PD Analysis
    • Method Development, Validation, and Transfer
      • Method Validation
      • Method Development
      • Method Transfer
  • Services
    • Pharmacokinetics (PK) Study
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • ADME Studies
    • Toxicology (Tox) Study
      • Dose Formulation Analysis
    • Biomarker Testing Services
      • Biomarker Assay List
    • Bioequivalence and Bioavailability Studies
    • Immunogenicity Testing
    • Bioanalytical Assay
      • Cell-based Assays
      • Cytotoxicity Assay
      • Biochemical Assay
      • Mechanism of Action (MOA) Studies
  • 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
    • 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
  • Request Quote
NorthEast Biolab Agile Bioanalysis Services CRO Request Quote

Expertise

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

            Services

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

                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

                      • 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

                                                      Request Quote

                                                        Contact Us

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                                                        • 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.
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                                                        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.

                                                        In our experience, this continual emphasis on the highest quality translates to reliable and reproducible bioanalytical data for our clients.

                                                        Still Have Questions About Your Bioanalysis?

                                                        Our Bioanalytical Assay Experts Are Eager to Help!
                                                        Speak To Our Scientists

                                                        Explore more about us

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

                                                        Expertise

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

                                                        Services

                                                        • Pharmacokinetics (PK) Study
                                                        • Toxicology (Tox) Study
                                                        • Biomarker Testing Services
                                                        • Bioequivalence and Bioavailability Studies
                                                        • Immunogenicity Testing
                                                        • 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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                                                        (203) 361 3780

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