---
name: NorthEast BioLab
slug: nebiolab
site: cro
website_domain: nebiolab.com
summary: Bioanalytical CRO providing PK/PD, immunogenicity (ADA/nAb), cytokine, and biomarker assays across LC-MS, Meso Scale Discovery, ELISA, and ddPCR platforms. Operates GLP/GCLP-compliant facilities and reports DEA and CT approval for Schedule I–IV bioanalysis.
tagline: Agile Bioanalytical Services CRO
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: 
tier2_domain_verified: false
updated_at: 2026-11-01T07:01:47.612Z
services_count: 13
modalities_count: 6
indications_count: 0
locations_count: 0
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# NorthEast BioLab

Agile Bioanalytical Services CRO

Listed on cro.directory.

## Summary

Bioanalytical CRO providing PK/PD, immunogenicity (ADA/nAb), cytokine, and biomarker assays across LC-MS, Meso Scale Discovery, ELISA, and ddPCR platforms. Operates GLP/GCLP-compliant facilities and reports DEA and CT approval for Schedule I–IV bioanalysis.

## Services

- Bioanalysis
- LC-MS Bioanalysis (Small Molecule)
- Ligand-Binding Bioanalysis (Large Molecule)
- Immunogenicity Assays (ADA / NAb)
- Biomarker Assays
- Flow Cytometry Services
- Analytical Method Development & Validation
- ICH Stability Studies
- Clinical Trial Services
- Central Laboratory Services
- Preclinical In Vivo Studies
- In Vivo PK / PD Studies
- In Vitro ADME / DMPK

## Modalities

- Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Vaccine
- Cell Therapy
- Gene Therapy

## Long description

## Bioanalytical CRO services

NorthEast BioLab is a bioanalytical contract research organization offering clinical, preclinical, and discovery-phase bioanalysis for biotech, pharmaceutical, and U.S. government sponsors.

### Services

- Pharmacokinetics (PK), PK/PD analysis, ADME and DMPK studies, toxicokinetics, dose formulation analysis, and bioequivalence studies
- Immunogenicity testing (ADA and NAb assays) and multiplex cytokine assays
- Bioanalytical assay development, validation, transfer, and sample analysis, including GLP and clinical method development
- Analytical testing for R&D and formulation needs
- Clinical CRO services, including central lab sample management and GCLP clinical bioanalysis
- Non-GLP preclinical research for biotech and academic investigators

### Platforms

The lab reports expertise in mass spectrometry (LC-MS/MS and HRMS), Meso Scale Discovery, ELISA, Luminex multiplex, flow cytometry, qPCR and ddPCR, cell-based and cytotoxicity assays, ELISpot and FluoroSpot, mechanism-of-action studies, and quantitative Western blot.

### Compliance and track record

The website states that its GLP/GCLP-compliant facilities have undergone multiple FDA audits and that the lab is approved by the DEA and CT for Schedule I–IV bioanalysis. It reports more than 20 years in bioanalysis, over 700 sponsor studies, over 500 custom assays, and work on more than 200 investigational drugs.

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_Profile last updated: 2026-11-01T07:01:47.612Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.