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      • HPLC Method Development Validation
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                                                              • Analytical Testing

                                                              Analytical Testing

                                                              Analytical testing services pertain to a wide range of chemical and microbiological assays. Analytical laboratory services include method development and validation, sample analysis for concentration confirmation, purity, homogeneity, and stability assays on preliminary formulations and finalized drug products for IND, NDA, and ANDA submissions. NorthEast BioLab offers sophisticated analytical testing laboratory services to help detect, measure, and analyze the performance of your drug or personal care product.

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

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                                                              Click below for answers to your Analytical Testing questions -
                                                              • What is Analytical Testing?
                                                                What is Analytical Testing?
                                                              • Which Analytical Testing services do we offer?
                                                                Which Analytical Testing services do we offer?
                                                              • Why choose us for your Analytical Laboratory Services?
                                                                Why choose us for your Analytical Laboratory Services?

                                                              Ask Us About Your Study

                                                              Analytical testing services pertain to a wide range of chemical and microbiological assays. Analytical laboratory services include method development and validation, sample analysis for concentration confirmation, purity, homogeneity, and stability assays on preliminary formulations and finalized drug products for IND, NDA, and ANDA submissions. NorthEast BioLab offers sophisticated analytical testing laboratory services to help detect, measure, and analyze the performance of your drug or personal care product.

                                                              SPEAK TO OUR SCIENTISTS

                                                              What is Analytical Testing?

                                                              Analytical Testing: Method Development to Sample Analysis

                                                              Analytical testing services allow assessment of chemical compounds or biopharmaceutical materials in a specific and sensitive manner. Demand for a variety of analytical testing services is increasingly growing across a broad array of industry verticals ranging from biotech, pharmaceutical, environment, and food to personal care companies.

                                                              Drug research and development personnel utilize analytical services laboratory to determine the chemical and biological properties of chemical compounds for further development and enhancement. These testing services provide information on both, the safety profile of a drug candidate as well as its therapeutic or health impact.

                                                              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.

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                                                              Explore Our Analytical Testing Services Lab CRO!
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                                                              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….

                                                              Learn More at our Learning Center

                                                              Which Analytical Testing services do we offer?

                                                              Analytical Testing services by NorthEast BioLab

                                                              NorthEast BioLab offers comprehensive analytical testing services for chemical entity evaluation as well as drug discovery and development. These drug testing and analysis services are provided using various analytical techniques include LC-MS/MS, LC/UV, LU/Fluorescence, ELISA Assay, Luminex, and Western Blot among other techniques.

                                                              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 analytical testing laboratory services:

                                                              Bioanalysis or Bioanalytical Testing

                                                              NorthEast BioLab offers the following bioanalysis services:

                                                              • Analysis of chemicals, drug, and metabolites
                                                              • Preclinical non-GLP and GLP analysis in
                                                                • Rodents – Rat, Mice
                                                                • Non-Rodents – Rabbit, Dog, Pig, Goat, Sheep, Non-human primate (NHP)
                                                              • Clinical studies ranging from Phase I -IV
                                                              • Bioavailability and bioequivalence studies
                                                              • Assessment of drug-drug interactions
                                                              • Chiral or enantiomeric separations
                                                              • Stabilization methods for analytes

                                                              Biomarker Testing

                                                              NorthEast BioLab performs biomarker tests to assess the exposure, susceptibility, or impact of a drug compound on an illness or disease. Specifically, our team offers biomarker analytical testing services below to ensure safe drug product for clinical trials:

                                                              • Fluid and tissue-based biomarkers
                                                              • Method development and qualification of novel biomarkers
                                                              • Rapid GLP validation of established qualified assays
                                                              • GCP measurement of biomarkers in biological samples from Clinical trials

                                                              Registered And Inspected By Various Regulatory Agencies

                                                              EGF Functions and Effects

                                                              Why choose us for your Analytical Laboratory Services?

                                                              Proficient Analytical Laboratory Services tailored to R&D needs of Biotech and Cosmetic Companies

                                                              NorthEast BioLab has in-depth expertise in analytical testing laboratory services to perform in-vitro and in-vivo testing of chemicals and assessing their efficacy for intended therapeutic value. We deliver superbly on characterization, purity, safety, and efficacy analysis of your various chemical formulations by our in-house chemistry and biology experts. Our veteran team has steadily developed outstanding processes and standard operating procedures (SOPs) for streamlining your drug testing and analysis given our 20+ years of experience as an analytical services laboratory. We are committed to developing and validating robust bioanalytical methods per FDA guidance, given your primary objective of expedited FDA drug approval.

                                                              Questions On Our Analytical Testing Lab CRO Services?

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                                                              Explore More Solutions

                                                              • Bioanalysis Bioanalysis
                                                              • GLP Laboratory GLP Laboratory
                                                              • Clinical CRO Clinical CRO
                                                              • Preclinical CRO Preclinical CRO
                                                              • Analytical Testing Analytical Testing
                                                              • Non-GLP Testing Non-GLP Testing

                                                              Expertise

                                                              • Liquid Chromatography Mass Spectrometry
                                                              • ELISA Method
                                                              • Meso Scale Discovery Assay
                                                              • Luminex Multiplex Assay
                                                              • LI-COR Odyssey Assay
                                                              • PK PD Analysis
                                                              • Method Development Validation and Transfer

                                                              Services

                                                              • Pharmacokinetics (PK) Study
                                                              • Toxicology (Tox) Study
                                                              • Immunogenicity Testing
                                                              • Biomarker Testing Services
                                                              • Bioequivalence and Bioavailability Studies
                                                              • 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

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                                                              • Case Study
                                                              • News and Events
                                                              • Testimonials
                                                              • Contact Us
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