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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
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                      • Non-GLP Testing
                        • Discovery and Research
                        • Cosmetic Testing

                      About Us

                      • Overview
                        • Why Us?
                          • Values
                            • Leadership
                              • Process
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                                  • Facility and Equipment
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                                                      Request Quote

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                                                        • EMA Good Clinical Practice (2016)

                                                        EMA Guideline For Good Clinical Practice E6(R2) Step 5 (2016)

                                                        Retrieved From
                                                        https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf

                                                        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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