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                                                              • Analytical Assay Method Transfer Services Lab

                                                              Swift And High-Value Analytical Method Transfer Services For Biotech!

                                                              • Streamlined Analytical Method Transfer And Validation At FDA Audited Lab For Your PK Studies & Biomarker Assays
                                                              • Analytical Method Transfer And Full Or Partial Validation For Your LC-MS Analysis, ELISA, Luminex, MSD, Or RT-qPCR Assay
                                                              • Full-Service Bioanalytical CRO Lab For Method Transfer And Assay Troubleshooting Or Optimization Services
                                                              • Custom Bioanalytical Method Transfer And QC Based Cross Validation At Industry-Leading Turnaround
                                                              Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)

                                                              Provide Your Bioanalysis Study Details

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                                                              Click below for answers to your Analytical Method Transfer questions -
                                                              • What Is Analytical Method Transfer?
                                                                What Is Analytical Method Transfer?
                                                              • Which Analytical Method Transfer services do we offer?
                                                                Which Analytical Method Transfer services do we offer?
                                                              • Why Choose us for your Analytical Method Transfer?
                                                                Why Choose us for your Analytical Method Transfer?

                                                              Ask Us About Your Study

                                                              Analytical Method Transfer (AMT) must be reported in adequate detail to allow assay reproduction and obtain data within acceptance criteria as per the US FDA’s relevant guidelines. Typically, Method Transfer is completed ahead of assay transition to a new bioanalytical facility. Among other reasons, this could be necessitated by the requirement to perform the sponsor assay in more stringent conditions, such as GMP/GLP/GCLP. NorthEast BioLab analysts are proficient in interpreting Analytical Method Transfer reports for GLP/GCLP Assay set up at our facility, as well as preparing detailed documentation for shifting sponsor assay to other GMP facilities and locations.

                                                              SPEAK TO OUR SCIENTISTS

                                                              What Is Analytical Method Transfer?

                                                              Analytical Method Transfer: Leverage and Improve Research Mode Bioanalysis

                                                              Analytical method transfer is a critical step in drug development that’s quite frequently encountered by biotech and pharma R&D personnel. Broadly, it is a documentation process that enables one laboratory (receiving laboratory) to set up and utilize an analytical test procedure that originated in another laboratory (sending laboratory). Method transfer ensures that the receiving lab has all pertinent method details, such as sample preparation approach, favorable equipment settings, and desired atmospheric conditions to reproduce the analytical test procedure systematically.

                                                              Proper method transfer minimizes unnecessary trial and error given the receiving laboratory takes method setup guidance from another lab successful with that method already. Often, the step takes place before the method gets validated at the sending lab given the receiving lab typically will have to validate the method anyway for generating data worthy of regulatory submission. Naturally, it is more resource, time, and cost effective to do the method transfer prior to validation. Method transfers can occur between different labs at the same testing site, or between different sites of the same company, or even between different companies and labs depending on a variety of scientific, financial, and human resources related factors. The requirements for the transfer such as extent of documentation, however, change based on the lifecycle stage of the method.

                                                              It’s important to have specific standard operating procedures in place to ensure the analytical method transfer is comprehensive and reliable. For instance, a detailed and well-written method protocol should be shared before the transfer process begins. Ideally, the sending lab should make its experts accessible to the receiving lab before the transfer as well. Finally, the receiving lab should test-run the procedure and flag potential issues for clarification before the transfer is completed.

                                                              What Our Sponsors Have to Say?

                                                              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 Analytical Assay Method Transfer Services Lab CRO!
                                                              SPEAK TO OUR SCIENTISTS

                                                              Which Analytical Method Transfer services do we offer?

                                                              Analytical Method Transfer Services by NorthEast BioLab

                                                              At NorthEast BioLab, we primarily focus on method transfer for pharmaceutical products or drugs in development. We specialize in providing bioanalytical methods and services for small molecules. These small, chemically manufactured molecules are classic active substances and continue to make up over 90 percent of the drugs in the market today. We guide our clients through key phases of the drug development process providing analytical method transfers during all phases of drug discovery and development

                                                              At NorthEast BioLab, we conduct method transfer/cross-validation using either quality controls or incurred study samples or both.

                                                              Our method transfer procedures rigorously evaluate the following parameters. Of course, this is just an indicative list that’s subject to shift focus significantly depending on the analyte at hand.

                                                              • Accuracy
                                                              • Precision
                                                              • Selectivity
                                                              • Specificity
                                                              • Stability
                                                              • Limits of Detection (LOD)
                                                              • Limit of quantitation (LOQ)

                                                              The parameters that are required in any method transfer depends on the desired results of the method transfer. The method transfer protocol defines the objectives, materials, and analytical procedures that need to be transferred and is the defining guideline for the entire process.

                                                              The Basic of Bioanalysis

                                                              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….

                                                              Read More at our Learning Center

                                                              Registered And Inspected By Various Regulatory Agencies

                                                              Why Choose us for your Analytical Method Transfer?

                                                              Fitting Analytical Method Transfer for Fast Turnaround and High ROI

                                                              Across the world, drug development companies are outsourcing bioanalysis to Contract Research Organisations. However, given the time-sensitive nature of drug development, finding the right partner is important. At NorthEast BioLab, we have over 15 years of experience in analytical method development, validation, and transfer. We understand that optimizing your costs and resources is critical during the drug development process and we do everything we can to help you get there.

                                                              We work with clients to use the type of analytical method transfer that is suited to their situation. We bring together our core strengths, operational excellence, regulatory expertise, and scientific experience to help you reach your goals faster.

                                                              Questions On Our Analytical Assay Method Transfer Lab CRO Services?

                                                              Our Experienced Scientists Are Ready To Help You, Today!
                                                              SPEAK TO OUR SCIENTISTS

                                                              Explore More Expertise

                                                              • HPLC Method Development Validation HPLC Method
                                                                Development Validation
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                                                              • Method Validation Method
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                                                              • Method Transfer Method
                                                                Transfer

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                                                              Services

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