sales@nebiolab.com Follow Up On Email
(203) 361 3780 Follow Up On Phone
NorthEast BioLab 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
NorthEast Biolab 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

                                                            Advanced Bioanalytical Services Lab CRO Trusted By Biotech Pioneers For Over 20 Years!

                                                            • Full-Service, GLP Bioanalysis For Biologics, Small Molecules, Cell/Gene Therapy
                                                            • Tailored, High-Value PK/PD, ADA/NAb, And Cytokine Bioanalysis Services CRO
                                                            • Preclinical, Clinical Bioanalytical Lab Services At Industry-Leading Turnaround
                                                            • High-Quality Bioanalytical Solutions Using LC-MS, ELISA, And qPCR Assays
                                                            speak to our scientists

                                                            Regulated And Inspected By:

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

                                                            NorthEast BioLab is by far the most responsive and thorough bioanalysis service provider.

                                                            VP, Bioanalytical Development

                                                            Lab
                                                            + Years Of Bioanalysis
                                                            + Small/Large Molecule Studies
                                                            + Custom Bioanalytical Assays
                                                            + Investigational Drugs
                                                            + Biomarker & Cytokine Assays

                                                            Full-Service Bioanalytical Assay Lab For Expedited Drug Development

                                                            Deep Subject Expertise

                                                            Our company specializes in Assay Development, Validation, and Sample Analysis on state-of-the-art bioanalytical lab platforms:

                                                            Mass Spectrometry (LC-MS)

                                                            Expert LC MS Bioanalyis Services For LC MS Method Development, Validation, And LC MS MS Analysis Testing Of Your Therapeutics And Biomarkers.

                                                            Learn More

                                                            Meso Scale Discovery (MSD) Assay

                                                            Outstanding Meso Scale Discovery Assay And MSD Assay Service For Your PK, Immunogenicity (ADA, nAb), And Mesoscale Cytokine Multiplex.

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                                                            ELISA Assay

                                                            Tailored ELISA Assay Development, ELISA Assay Validation, And ELISA Testing Services Lab For Biologics, Vaccines, Peptides, And Biomarkers.

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                                                            qPCR Analysis, dPCR Assay

                                                            Comprehensive qPCR Analysis Services And ddPCR Assays For Gene Expression, miRNA, CNV Assays, Vector Quantification, And Rare Event Detection

                                                            Learn More

                                                            LI-COR Odyssey (WB, ICW)

                                                            Rapid Western Blot Analysis, In Cell Western Assay, And Protein Gel Imaging Using LI-COR Odyssey With Enhanced Data Quality And Sustained Sensitivity.

                                                            Learn More
                                                            View All Expertise

                                                            Science Based Services

                                                            Our veteran scientists offer the full spectrum of bioanalytical lab services to help achieve your drug development and discovery goals:

                                                            Pharmacokinetics (PK) Study

                                                            Excellent Pharmacokinetics CRO, PK Assay Sample Analysis, And SAD MAD Pharmacokinetics Study Services For Drug And Metabolite Bioanalysis.

                                                            Learn More

                                                            ADA Assay, Neutralizing Antibody Assay

                                                            Customized ADA Assay Development And Neutralizing Antibody Assay Development Services For Risk-Based Immunogenicity Assay Of Therapeutics.

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                                                            Cytokine Analysis, Biomarker Assay

                                                            Expedited Cytokine Assay Lab, Biomarker Analysis Services For Your Clinical Study And Preclinical Testing As Per FDA, EMA, And ICH Guidelines.

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                                                            Cell Based Assays

                                                            Biologically Relevant Cell-Based Assay Utilizing Mechanism-Of-Action (MOA) For Quality Control, Potency Testing, MOA Evaluation, Neutralizing Antibody Detection, Etc.

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                                                            Bioanalytical Assay Validation

                                                            Swift Bioanalytical Assay Development And Bioanalytical Assay Validation Services For Your Therpeutics And Biomarkers As Per FDA And ICH Guidelines.

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                                                            View All Services

                                                            Ready To Tackle Your Bioanalytical Challenges? Our Veteran Team Is Here To Assist You At Every Step.

                                                            SPEAK TO OUR SCIENTISTS

                                                            Comprehensive Bioanalytical CRO Solutions For Small Molecules, Biologics, Antibodies, Vaccines, Cell, And Gene Therapies

                                                            Clinical, Preclinical, And Discovery Phase Bioanalytical Solutions Lab For Biotech And US Government Efforts

                                                            Method Development, Validation, And Transfer

                                                            Complete suite of bioanlyatical assay lab services, including discovery, GLP, and clinical method development, validation, transfer, and much more

                                                            GLP Laboratory Services

                                                            Fully compliant good laboratory practice (GLP) bioanlaytical lab to ensure high integrity of your non-clinical GLP studies for EMA or FDA submissions.

                                                            Clinical CRO Services

                                                            Clinical trials CRO and GCLP services from protocol review to submission ready clinical bioanalysis data for biotech and US government sponsors

                                                            Preclinical CRO Services

                                                            Preclinical CRO trusted by our sponsors to drive GLP preclinical study and Non-GLP preclinical research services for successful IND filing.

                                                            Analytical Testing Services

                                                            Topnotch analytical testing and analytical laboratory services tailored to the R&D needs of biotech, pharma, and US government entities

                                                            Non-GLP Discovery Bioanalysis

                                                            Expert Non-GLP Study Preclinical Tox (PK/TK), Immunognecity, And Pharmacodynamic Biomarker Services For Biotech And Academic Investigators

                                                            Our Experienced Professionals Can Get Immediately Started On Your Crucial Bioanalytical Studies.

                                                            SPEAK TO OUR SCIENTISTS

                                                            Choose NorthEast BioLab as Your Trusted Bioanalytical CRO!

                                                            With over two decades of hands-on experience working with hundreds of novel and approved drugs, NorthEast BioLab is the reliable choice for all your bioanalytical service needs.

                                                              • 20+ years track record of accelerating Pharmacokinetics (PK/PD), Immunogenicity (ADA/nAb), Cytokine, and Cell-Based Assays
                                                              • Deep expertise in Mass Spectrometry, Meso Scale Discovery, ELISA, qPCR/dPCR, Western Blot, and other leading bioanalysis platforms
                                                              • GLP/GCLP compliant facilities, successfully undergone multiple FDA audits, and approved by DEA and CT for Schedule II-IV bionalysis
                                                              • Committed to providing top-notch bioanalytical lab services backed by our industry experience, assay lab expertise, and regulatory knowledge
                                                            Drug Development Expertise

                                                            Drug Development Expertise

                                                            • Get It Right, The First Time – Veteran Scientists
                                                            • Tailored, High-Quality – Avoid Delays, Budget Overrun
                                                            • Regulatory Awareness – 30+ Years In Life Sciences
                                                            • Diverse Sponsors – Biotech, Fortune 500, NIH, Etc.
                                                            Symbiotic Business Partnership

                                                            Symbiotic Business Partnership

                                                            • Long-Term Horizon – No Study Or Pilot Too Small
                                                            • Attractive Pricing – Value, Proof-of-Concept Focused
                                                            • One-Stop Shop – In-vitro DMPK To GLP/Clinical Studies
                                                            • Solution Provider Mindset – 3rd Party Collaborations
                                                            Distinguished Service Offering

                                                            Distinguished Service Offering

                                                            • Turnaround – ~3-5 Weeks Scheduling, Delivery
                                                            • Flexibility – Free SOW Change Or Expedited Analysis
                                                            • Transparency – Scientist-To-Scientist Communication
                                                            • Sponsor Control – Fine-Tuned Reports Per Feedback
                                                            LEARN MORE ABOUT US

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

                                                            Connect With Us For A Reference Call With Them!

                                                            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.

                                                            VP, Bioanalytical Development

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

                                                            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.

                                                            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.

                                                            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.

                                                            Do Not Miss Out On This Essential Partnership, Contact Us Today To Expedite Your Bioanalytical Studies.

                                                            SPEAK TO OUR SCIENTISTS

                                                            Explore Resource Center To Access Our Bioanalytical Expertise

                                                            Original And Curated Bioanalytical Solutions, Bioanalysis Ideas, And Assay Development Plus Validation Insights

                                                            Array

                                                            Learning Center

                                                            • A Complete Guide On ADA Assay Development, Immunogenicity Assessment, And FDA Guidance

                                                              A comprehensive immunogenicity assessment of therapeutics through robust and reproducible…

                                                            • Fundamentals Of Liquid Chromatography Mass Spectrometry (LC-MS/MS)

                                                              Over the past 15 years, Liquid Chromatography Mass Spectrometry (LC-MS/MS) has emerged…

                                                            View All
                                                            Array

                                                            Blog

                                                            • Introduction To Multiplex Cytokine Analysis Using Meso Scale Discovery

                                                              Cytokines are soluble peptides, proteins, and glycoproteins that modulate the immune system. They are crucial…

                                                            • Joint Negative And Positive Mode Development For Combination LC-MS/MS Method

                                                              Combining mass spectrometry (MS) with chromatographic approaches is always desirable as MS is highly sensitive and specific…

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                                                            Array

                                                            Case Study

                                                            • Monoclonal Antibody Fragment Immunoassay Development And Validation

                                                              An immunoassay that met the client mandated sensitivity was successfully developed and validated as per…

                                                            • LC-MS/MS Method Development And Validation For Quantitating Amino Acids In Human Plasma

                                                              Develop and validate a robust LC-MS/MS method for quantitating multiple amino acids in human plasma.

                                                            View All
                                                            Array

                                                            Video Brochures

                                                            • Real Time QPCR Services Or DdPCR Assay

                                                              Partner with us for your real time quantitative qPCR analysis and digital dPCR assay services…

                                                            • Meso Scale Discovery: Cytokine Multiplex Assay

                                                              Meso Scale Discovery (MSD) based cytokine multiplex assay development, validation, and sample analysis…

                                                            View All

                                                            Rely On Our Results Driven Growth Mindset To Troubleshoot Your Bioanalytical Assays.

                                                            SPEAK TO OUR SCIENTISTS

                                                            FAQs: Our Bioanalysis And Bioanalytical Lab Services

                                                            Answers To Bioanalysis And Bioanalytical Lab Services Questions Popular Among Our Potential Clients.

                                                            What are Bioanalytical Services?

                                                            Bioanalytical Services entail the assessment of xenobiotics, biotics, and other analytes of interest in various biological matrices. Specifically, these lab services involve the quantitation of biologics, drugs, metabolites, cytokines, biomarkers, nucleic acids, genes, etc, during integral lab experiments related to therapeutic safety and efficacy. Bioanalytical labs play a crucial role in acquiring essential data during drug research and development, given their extensive portfolio of bioanalytical services such as Pharmacokinetics (PK), ADA Assay, Neutralizing Antibody Assay, Cytokine Analysis, Biomarker Assay, and Bioanalytical Assay Validation. Their deep subject matter expertise and technical know-how ensure accurate analysis and reproducible results, making them an indispensable partner for advancing the patient heath-centric mission of new-age biotechnology companies.

                                                            Do you offer large molecule, small molecule, or cell and gene therapy Bioanalytical Services?

                                                            All of the Above! We offer a full suite of bioanalytical services in our US-based, state-of-the-art 19,000 sq ft bioanalytical laboratory. Our gene therapy and large molecule bioanalysis encompass customized bioanalytical assay development and fit-for-purpose or GLP method validation utilizing ELISA, Meso Scale Discovery, Real-Time qPCR, Digital dPCR, and Western Blotting platforms. Additionally, our cell-therapy capabilities extend to Neutralizing Antibody Assay, Cytotoxicity Assay, Biochemical Assay, and Mechanism Of Action (MoA) studies.

                                                            Our small molecule bioanalysis includes mass spectrometry and HPLC lab with deep expertise in PK PD Analysis, DMPK, ADME Studies, Tox (TK) Study, and Biomarker Assay. Trust our bioanalytical lab with 20+ years track record on 600+ bioanalysis studies to generate reliable and reproducible data for your IND package and NDA submission.

                                                            Do you develop new methods or transfer and validate existing methods during Bioanalytical Services?

                                                            Both! NorthEast BioAnlaytical Laboratory provides comprehensive bioanalytical services covering method development, transfer, and validation. We perform rapid method development by optimizing sample preparation and other bioanalytical assay components as needed for the targeted calibration range and acceptance criteria. Our bioanalytical experts excel in method transfer between labs, personnel, and equipment. If required, we gladly adjust your method for straightforward validation or if the method transfer fails due to incomplete or incorrect information.

                                                            Our reliable bioanalytical services ensure reliable and reproducible measurements of your analytes in a given biological matrix. Following FDA/EMA/ICH guidelines, we run full three-day LC-MS/MS or six-day ELISA method validation to evaluate precision and accuracy. Subsequently, our assays examine selectivity, specificity, recovery, carryover, matrix effect, and process stability. Ultimately, we assess long-term storage stability for your therapeutics and biomarkers. Trust our premium bioanalytical lab for efficient and precise analysis of your crucial samples.

                                                            How do I estimate the budget for my Bioanalytical Services needs?

                                                            NorthEast BioAnalytical Lab is differentiated as the unwavering provider of comprehensive bioanalytical services with over 20 years of expertise and industry leadership. Our distinguished team of seasoned scientists has successfully executed more than 600 studies for Investigational New Drug (IND), New Drug Application (NDA), Biologic License Application (BLA), and Generics Application (ANDA) filings with the US FDA. We possess an astute understanding of the critical significance of budget and timeline, having navigated these challenges ourselves as a fast growing, small business. Speak to our scientists today to explore how our top-notch bioanalytical services can bolster your groundbreaking drug development initiatives.

                                                            What are your typical turnaround times for Bioanalytical Services?

                                                            Generally, we need just four-to-six weeks for most bioanalytical services such as method development and validation following the issuance of purchase order and securing of all assay supplies. Afterward, we need another five-to-ten days for submitting your audited bioanalytical lab report with complete details of method validation experiments and a few batches of sample analysis data. Please note that turnaround times for your method set-up and sample analysis may vary based on i) Specific Ligand Binding Assay and Materials (e.g., antigen/antibody pair availability, etc), ii) Mass Spectrometry Method and Materials (e.g., sample preparation, extended run time/duplicate injection, assay with multiple analytes / metabolites, Other Materials – required columns, well plates, and materials etc), and iii) Test article, Formulation, or Control Matrices – large quantities, controlled substances, specific vehicles, exotic species, uncommon matrices, etc

                                                            Do you follow the FDA and ICH guidelines for Bioanalytical Services?

                                                            Yes! NorthEast BioLab is registered with and has been successfully audited by the US Food and Drug Administration (FDA) multiple times for good laboratory practices. We also keep our registrations in good standing with the United States Drug Enforcement Administration (DEA) and the Connecticut State Department of Consumer Protection.

                                                            Our clients can rest assured that we are in full compliance with all relevant industry regulations, e.g., FDA validation guidance and ICH guidelines for method validation. By stringently following these regulations, Northeast BioAnalytical Laboratories seamlessly completes each study that we accept. Please contact us if you would like additional proof or documentation of our credentials and certifications.

                                                            How do you work with third-party providers – CROs, vivariums, other labs, and consultants?

                                                            As your trusted bioanalytical lab, NorthEast BioLab flexibly partners with a vast network of affiliates to deliver requested analytical testing, preclinical, and clinical CRO solutions. With us, you’ll not only get access to first-class, client-focused bioanalytical services but also recommendations for preferred life sciences consultants and in-vivo, pathology, and materials providers. Speak with our veteran team to get head-start on your study and beat competitors to market.

                                                            Questions On Our Small Molecule, Cell/Gene Therapy, And Large Molecule Bioanalysis Lab CRO Services?

                                                            SPEAK TO OUR SCIENTISTS

                                                            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

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                                                            We Will Respond Within 1 Business Day

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