sales@nebiolab.com Email Your Inquiry
(203) 361 3780 Speak to Our Scientists
NorthEast BioLab Agile Bioanalysis Services CRO
  • Expertise
    • All Expertise
    • Liquid Chromatography Mass Spectrometry
      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
    • Meso Scale Discovery Assay
    • Luminex Multiplex Assay
    • LI-COR Odyssey Assay
    • PK PD Analysis
    • Method Development, Validation, and Transfer
      • Method Validation
      • Method Development
      • Method Transfer
  • Services
    • All Services
    • Pharmacokinetics (PK) Study
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • ADME Studies
    • Toxicology (Tox) Study
      • Dose Formulation Analysis
    • ADA Assay Immunogenicity Testing
    • Biomarker Testing Services
      • Biomarker Assay List
    • Bioequivalence and Bioavailability Studies
    • Bioanalytical Assay
      • Biochemical Assay
      • Mechanism of Action (MOA) Studies
      • Cell-based Assays
      • Cytotoxicity Assay
  • Solutions
    • All Solutions
    • 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
    • News and Events
    • Testimonials
    • Contact Us
  • Request Quote
NorthEast Biolab Agile Bioanalysis Services CRO Request Quote

Expertise

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

              Services

              • All Services
                • Pharmacokinetics (PK) Study
                  • Drug Metabolism and Pharmacokinetics (DMPK)
                  • ADME Studies
                • Toxicology (Tox) Study
                  • Dose Formulation Analysis
                • ADA Assay Immunogenicity Testing
                  • Biomarker Testing Services
                    • Biomarker Assay List
                  • Bioequivalence and Bioavailability Studies
                    • Bioanalytical Assay
                      • Biochemical Assay
                      • Mechanism of Action (MOA) Studies
                      • Cell-based Assays
                      • Cytotoxicity Assay

                    Solutions

                    • All Solutions
                      • 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
                                                      • News and Events
                                                        • Testimonials
                                                          • Contact Us

                                                            Request Quote

                                                              Contact Us

                                                              Advanced Bioanalytical Lab Services CRO Trusted By Biotech And Pharma Pioneers Over 20+ Years!

                                                              • Full-Service, GLP Bioanalysis For Biologics And Small Molecules
                                                              • Preclinical, Clinical Bioanalytical Lab Services At Industry-Leading Turnaround
                                                              • Tailored, High-Value PK, ADA, And Cytokine Bioanalysis Services CRO
                                                              • High-Quality Bioanalytical Solutions From Assay Development To Sample Analysis
                                                              speak to our scientists

                                                              Learn more about Working with Us.
                                                              Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)

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

                                                              Director, PK | Biotech acquired by Top 10 Pharma View all Testimonial
                                                              0+ Years Of Bioanalysis
                                                              0+ Small/Large Molecule Studies
                                                              0+ Custom Bioanalytical Methods
                                                              0+ Investigational Drugs
                                                              0+ Biomarker Assays

                                                              Custom Bioanalytical Solutions to Accelerate Your Drug Approval

                                                              Deep Subject Expertise

                                                              NorthEast BioLab specializes in assay development, validation, and sample analysis as well as the following bioanalysis platform.
                                                              • Liquid Chromatography Mass Spectrometry
                                                              • ELISA Method
                                                              • Meso Scale Discovery Assay
                                                              • Luminex Multiplex Assay
                                                              • LI-COR Odyssey Assay
                                                              • PK PD Analysis
                                                              View All Expertise

                                                              Science based Services

                                                              NorthEast BioLab has distinct track record of advancing your research and GLP bioanalysis services from drug discovery to development and beyond.

                                                              • Pharmacokinetics (PK) Study
                                                              • Toxicology (Tox) Study
                                                              • ADA Assay Immunogenicity Testing
                                                              • Biomarker Testing Services
                                                              • Bioequivalence and Bioavailability Studies
                                                              • Bioanalytical Assay
                                                              View all Services

                                                              Ready To Take The First Step, Today?

                                                              Explore Our Small Molecule And Large Molecule Bioanalysis Services Lab CRO!
                                                              SPEAK TO OUR SCIENTISTS

                                                              Full Range of Solutions

                                                              NorthEast BioLab provides comprehensive clinical, preclinical, and discovery phase bioanalytical solutions to top biotech, pharma, and personal care companies.

                                                              Small Molecule And Large Molecule Bioanalysis Lab Services

                                                              We offer a full breadth of bioanalysis services spanning drug discovery, assay development and validation, and sample analysis to demonstrate proof-of-concept (PoC) or achieve submission-ready data.

                                                              Clinical Trials Bioanalysis CRO Lab Services

                                                              We transfer validated methods from animal to human matrices during this phase. In addition to bioanalysis, we could provide central lab services such as custom kits and sample management to your clinical sites.

                                                              GLP And Non-GLP Preclinical Study Research And CRO Bioanalysis Services

                                                              We handle the full breadth of your DMPK and dosage range studies using non-validated methods ahead of lead identification. Afterward, we perform method validation and sample analysis to conduct GLP Tox studies.

                                                              Analytical Testing

                                                              We offer bioanalytical lab services for chemicals and biologics. Among other techniques, these bioanalytical solutions are provided using LC-MS/MS, ELISA, MSD Quickplex, Luminex Multiplex, Western Blot, and qPCR.

                                                              View all Solutions

                                                              Why Choose NorthEast BioLab for Bioanalysis?

                                                              NorthEast BioLab is a bioanalytical lab with 20+ years experience in providing small and large molecule bioanalysis for clinical, preclinical, and drug discovery studies. Our team has an excellent track record of advancing Pharmacokinetics (PK), Bioavailability and Bioequivalence (BA/BE), Toxicokinetics (TK), Immunogenicity (ADA), Biomarker Testing, and Custom Assays. We offer Method Development and Validation using LC-MS/MS, ELISA, MSD ECL, Luminex Multiplex, Western Blot, and qPCR, among other technologies. We are a GLP/GCLP compliant, FDA audited, and DEA & CT State Schedule II-IV approved facility.

                                                              Your browser does not support the video tag.
                                                              Drug Development Expertise

                                                              Drug Development Expertise

                                                              • Get it right in first go
                                                              • Rapid, high-quality bioanalysis
                                                              • Regulatory awareness
                                                              • Diversified client base
                                                              Symbiotic Business Partnership

                                                              Symbiotic Business Partnership

                                                              • Long-term horizon
                                                              • Attractive Pricing
                                                              • One stop shop
                                                              • Solution provider mindset
                                                              Distinguished Service Offering

                                                              Distinguished Service Offering

                                                              • Turnaround
                                                              • Flexibilty
                                                              • Transparency
                                                              • Sponsor Control
                                                              Know more about us

                                                              Our Latest Content

                                                              Learning Center

                                                              • Complete Guide On Anti Drug Antibody (ADA) Assay Development, Immunogenicity Assessment, And...

                                                                A comprehensive immunogenicity assessment of therapeutics through robust and reproducible anti-drug antibody (ADA) assay development...

                                                              • Meso Scale Discovery: ECL Multiplex Assays For Cytokine ELISA, Immunognecicity, & PK

                                                                Meso Scale Discovery Electrochemiluminescence (ECL) Assays are an excellent singleplex and multiplex platform for assessing...

                                                              View all Articles

                                                              Blog

                                                              • What are Matrix Effect in Liquid Chromatography Mass Spectrometry?

                                                                Matrix Effects are the suppressing or enhancing properties of a co-eluting compound from a biological...

                                                              • What are the Best Practices of LC-MS/MS Internal Standards?

                                                                In an ideal scenario, a typical solution that is equally injected and then tested multiple...

                                                              View all Blogs

                                                              Case Study

                                                              • Method Development and Validation for Plasma Sample Analysis

                                                                Sample preparation and liquid chromatography are sometimes ignored during method development and validation given the...

                                                              • What is Incurred Sample Reanalysis (ISR)?

                                                                Bioanalytical assays are widely used to quantify drugs and their metabolites in a variety of...

                                                              View All Case Studies
                                                              We create / curate best offers, ideas, and insights just for you.

                                                              Testimonials

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

                                                              Director, PK

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

                                                              Head, PK

                                                              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, Development Operations
                                                              View all Testimonials

                                                              FAQs: Our Bioanalysis and Bioanalytical Lab Services

                                                              Answers to bioanalysis and bioanalytical lab services questions popular among our potential clients.

                                                              What is Bioanalysis?

                                                              Bioanalysis is a field of analytical and bioanalytical chemistry spanning the assessment of xenobiotics, biotics, and other analytes in biological matrices. In drug discovery and development, the role of bioanalytics is quantitation of drug compounds, metabolites, and biomarkers, etc. Extensive bioanalytical services such as pharmacokinetics (PK), toxicokinetics (TK), and bioequivalence of drugs are necessary during drug R&D to acquire the essential bioanalytical data.

                                                              Do you offer small molecule or large molecule bioanalysis?

                                                              Both! We offer small molecule bioanalysis utilizing LC-MS/MS, HPLC Fluorescence, and HPLC – UV. Our team has remarkable experience in PK sample analysis and TK safety testing using mass spectrometric and chromatographic bioanalytics.

                                                              Our large molecule bioanalysis consists of customized assays using ELISA, Luminex, and biology kits. Other bioanalytical lab capabilities include biomarker testing, cell-based assay, immunogenicity testing, biochemical assay, and Mechanism of Action (MoA) studies.

                                                              Do you develop new methods or transfer and validate existing methods for bioanalysis?

                                                              Both! We perform robust method development by optimizing sample preparation and instrument conditions as per targeted calibration curve and other bioanalysis parameters. Our veteran team is adept at method transfer to new bioanalytics personnel or equipment. We gladly modify your method for straightforward validation or if the transfer fails due to incomplete or incorrect information.

                                                              We run fit-for-purpose full three-day LC-MS/MS or six-day ELISA method validation to evaluate selectivity, specificity, sensitivity, precision, and accuracy. Here, we examine extraction recovery, carryover, matrix effect, and matrix suppression as well as ascertain process stability. We further assess the drug and biomarker stability during sample processing, analysis, and long-term storage.

                                                              How do I estimate the budget for my bioanalysis needs?

                                                              NorthEast BioLab has provided bioanalytical services in 500+ studies for Investigational New Drug (IND), New Drug Application (NDA), Generics Application (ANDA), and Biologic License Application (BLA) filings with the US FDA. Our team of veteran scientists would help put together the budget and timeline for your bioanalysis needs. Contact NorthEast BioAnalytical Laboratories today to discuss your drug development projects.

                                                              What are your typical turnaround times for bioanalytical services?

                                                              Generally, we need just four weeks for bioanalytical services such as method development and validation following the purchase order. Afterward, we need ten days for submitting your audited bioanalytical lab report with complete details of 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 methods (e.g., chiral separation, extended run time/duplicate injection, assay with multiple analytes / metabolites), ii) Test article or formulation – large quantities, controlled substances, specific vehicles and iii) Other Materials – required columns, well plates, and materials/matrices.

                                                              Do you follow the FDA and ICH guidelines for bioanalytical method validation?

                                                              Yes! NorthEast BioLab is registered with and has been 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.

                                                              Meet Our Bioanalysis Experts

                                                              Questions On Our Small Molecule And Large Molecule Bioanalysis Lab CRO Services?

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

                                                              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
                                                              • ADA Assay 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

                                                              • Learning Center
                                                              • Blog
                                                              • Case Study
                                                              • News and Events
                                                              • Testimonials
                                                              • Contact Us
                                                              NorthEast BioLab Logo

                                                              35 Worth Ave, Hamden, CT 06518

                                                              sales@nebiolab.com
                                                              (203) 361 3780

                                                              Consult with a Scientist Now

                                                              We Will Contact You 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