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    Click below for answers to your Method Development, Validation, and Transfer questions -

    Ask Us About Your Study

    Our scientists utilize effective method development, transfer, set-up, and validation techniques to identify, separate, and quantitate drug and metabolites in biological fluids. We provide the following method based services.

    SPEAK TO OUR SCIENTISTS

    What Is Method Development?

    • Reverse engineer and rapidly transition between species/matrices
    • Recommend equipment per molecule and sensitivity (LC-MS vs. ELISA)
    • Optimize sample preparation and instrument conditions
    • Iterate per target curve range, Cmax, Tmax, and AUC
    • Identify blank matrix, anticoagulant, reference and internal standard
    • Ensure analyte stability and apply stabilizer as necessary

    Sponsors Love Our Bioanalytical Laboratory Services For Top Quality And Industry Leading Turnaround

    Connect With Us For A Reference Call With Them!

    NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.

    We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

    We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.

    We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.

    We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

    NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.

    NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

    NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

    NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.

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

    We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

    Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

    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.

    Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

    This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.

    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.

    NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.

    We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

    We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.

    We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.

    We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

    NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.

    NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

    NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

    NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.

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

    We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

    Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

    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.

    Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

    This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.

    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.

    Tackle Your Method Development/Transfer And Validation

    SPEAK TO OUR SCIENTISTS

    What Is Method Transfer, Set-up, and Cross-Validation?

    • Qualify and transfer from another lab to new equipment/analyst
    • Modify if transfer failed due to incomplete or incorrect information
    • Adjust for robust and straightforward method validation downstream
    • Prepare calibration standards and quality controls plus perform a test run
    • Cross-validate using unknown quality control samples and incurred samples

    Don’t Wait, Start Your Method Development/Transfer And Validation

    SPEAK TO OUR SCIENTISTS

    What Is Method Validation?

    • Run fit-for-purpose full three-day LC-MS/MS or six-day ELISA validation
    • Evaluate method selectivity, specificity, sensitivity, precision, and accuracy
    • Ascertain process stability – short term benchtop, autosampler, freeze-thaw
    • Examine extraction recovery, carryover, matrix effect, and matrix suppression
    • Assess the stability of drugs and biomarkers in bio matrices during sample processing, analysis, and long-term storage at various time points

    The Basics of Bioanalysis

    Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….

    Trust Our Method Development/Transfer And Validation Lab CRO Services.

    SPEAK TO OUR SCIENTISTS

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