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Expertise

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

        Services

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

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                  • Clinical CRO
                    • Clinical Trial Sample Management and Storage
                  • Preclinical CRO
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                      • Discovery and Research
                      • Cosmetic Testing

                    About Us

                    • About Us
                      • Overview
                        • Why Us?
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                              • Process
                                • Quality and Compliance
                                  • Facility and Equipment
                                    • Therapeutic Areas
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                                        • 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

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                                        • Learning Center
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                                            • Case Study
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                                                    Request Quote

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                                                      • Bioanalytical Method Validation (2019)

                                                      FDA M10 Bioanalytical Method Validation (2019)

                                                      Retrieved From
                                                      https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation

                                                      Expertise

                                                      • Liquid Chromatography Mass Spectrometry
                                                      • ELISA Method
                                                      • Meso Scale Discovery Assay
                                                      • LI-COR Odyssey Assay
                                                      • Method Development Validation and Transfer

                                                      Services

                                                      • Pharmacokinetics (PK) Study
                                                      • ADA Assay Immunogenicity Testing
                                                      • Biomarker Testing Services
                                                      • Bioanalytical Assay

                                                      Solutions

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                                                      • Clinical CRO
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                                                      • Analytical Testing
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                                                      About Us

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

                                                      Resources

                                                      • Learning Center
                                                      • Blog
                                                      • Case Study
                                                      • News and Events
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