sales@nebiolab.com Follow Up On Email
(203) 361 3780 Follow Up On Phone
Agile Bioanalytical Services CRO
  • Expertise
    • All Expertise
    • Mass Spectrometry (LC-MS)
      • Mass Spectrometry Services
      • HPLC Lab Services
    • Meso Scale Discovery Assay
    • ELISA Assay
      • Luminex Multiplex Assay
    • qPCR Analysis, dPCR Assay
    • LI-COR Odyssey (WB, ICW)
  • Services
    • All Services
    • Pharmacokinetics (PK) Study
      • Toxicology (Tox) Study
      • Dose Formulation Analysis
      • PK PD Analysis
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • ADME Studies
      • Bioequivalence and Bioavailability Studies
    • ADA Assay, Neutralizing Antibody Assay
    • Cytokine Analysis, Biomarker Assay
      • Biomarker Assay List
    • Cell-Based Assays
      • Mechanism of Action (MOA) Studies
      • Cytotoxicity Assay
      • Biochemical Assay
    • Bioanalytical Assay Validation
  • Solutions
    • All Solutions
    • Method Development, Validation, And Transfer
      • Method Validation
      • Method Development
      • Method Transfer
    • 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
    • About Us
    • Overview
    • Why Us?
    • Values
    • Leadership
    • Process
    • Quality and Compliance
    • Facility and Equipment
    • Therapeutic Areas
    • Partners
    • 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
  • Resources
    • Learning Center
    • Blog
    • Case Study
    • Video Brochures
    • News and Events
    • Testimonials
    • Contact Us
  • Request Quote
Agile Bioanalytical Services CRO Request Quote

Expertise

  • All Expertise
    • Mass Spectrometry (LC-MS)
      • Mass Spectrometry Services
      • HPLC Lab Services
    • Meso Scale Discovery Assay
      • ELISA Assay
        • Luminex Multiplex Assay
      • qPCR Analysis, dPCR Assay
        • LI-COR Odyssey (WB, ICW)

          Services

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

                Solutions

                • All Solutions
                  • Method Development, Validation, And Transfer
                    • Method Validation
                    • Method Development
                    • Method Transfer
                  • 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

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

                                            Resources

                                            • Learning Center
                                              • Blog
                                                • Case Study
                                                  • Video Brochures
                                                    • News and Events
                                                      • Testimonials
                                                        • Contact Us

                                                          Request Quote

                                                            Contact Us

                                                            NorthEast BioLab Logo Agile Bioanalysis Services CRO
                                                            Request Quote Contact Us
                                                            • Home
                                                            • 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

                                                            Regulated And Inspected By:

                                                            Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)

                                                            Provide Your Bioanalysis Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Lab
                                                            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.

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

                                                            Connect With Us For A Reference Call With Them!

                                                            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 Dir., 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. Dir., 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.

                                                            Dir., 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 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 Solutions

                                                            • Method Validation Method
                                                              Validation
                                                            • Method Development Method
                                                              Development
                                                            • Clinical Trial Sample Management and Storage Clinical Trial Sample Management and Storage
                                                            • Analytical Quantitation Analytical
                                                              Quantitation
                                                            • Discovery and Research Discovery and
                                                              Research
                                                            • Cosmetic Testing Cosmetic
                                                              Testing

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • qPCR Analysis, dPCR Assay
                                                            • LI-COR Odyssey (WB, ICW)

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Cytokine Analysis, Biomarker Assay
                                                            • Cell-Based Assay
                                                            • Bioanalytical Assay Validation

                                                            Solutions

                                                            • Method Development, Validation, And Transfer
                                                            • 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
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
                                                            NorthEast BioLab Logo

                                                            35 Worth Ave, Hamden, CT 06518

                                                            sales@nebiolab.comFollow Up On Email
                                                            (203) 361 3780Follow Up On Phone

                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies
                                                            • Food and Drug Administration (FDA)
                                                            • United States Drug Enforcement Administration
                                                            • Connecticut State Department of Consumer Protection
                                                            • Privacy Policy
                                                            • Terms of Use
                                                            • Sitemap
                                                            © 2019 - 2025, NorthEast BioAnalytical Laboratories LLC. All rights reserved.

                                                            How Can We Help?

                                                            I agree to receive emails, calls, and messages, etc from NorthEast BioLab.

                                                            Before you go! Get
                                                            your FREE Download:

                                                            Top 7 Hidden Pitfalls to your Bioanalytical Milestones

                                                            Step by step guide on how to accelerate your drug approval

                                                            • Addressing Main Constraints
                                                            • Research Best Practices
                                                            • The Economic Advantage
                                                            • Critical Decision Marketing Mode Easy
                                                            • Legal Documentation Checklist
                                                            We won’t share your email, ever, See our privacy policy

                                                            No thanks, I don’t need to improve my drug approval process