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NorthernBio

Preclinical CRO specializing in targeted drug delivery, molecular biology, and bioanalysis with three GLP-compliant Michigan facilities.

Michigan-based preclinical CRO specializing in targeted drug delivery, molecular biology, and bioanalysis with three GLP-compliant facilities supporting non-GLP and GLP safety assessment studies. Headquartered in Muskegon, United States.

Phases

Indications / Therapeutic Areas

Services

Technical specifications & accreditations

Accreditations

About this organization

NorthernBio is a preclinical contract research organization (CRO) headquartered in Michigan with three GLP-compliant research and development facilities. The company specializes in targeted drug delivery, molecular biology, and bioanalysis to support novel therapeutics development.

Core Services

  • In Vivo Research: Non-GLP and GLP-compliant safety assessment solutions using advanced surgical techniques
  • Bioanalytical Services: Advanced molecular biological techniques and ligand binding assays
  • Therapeutic Area Expertise: Neuroscience, ophthalmology, cardiovascular, metabolic, and rare disease research
  • Surgical Models: Large animal and rodent research capabilities
  • Regulatory Support: Customized preclinical studies designed to facilitate regulatory approval

Facilities

  • Muskegon facility: Designed for pre-clinical studies in large animal species
  • Norton Shores facility: Dedicated to high-quality rodent and ophthalmology research
  • Portage facility: Specializes in molecular biology and bioanalysis supporting preclinical and clinical trials

Quality & Compliance

NorthernBio maintains an independent quality assurance unit that monitors all facility and GLP study activities. The team integrates quality standards for GLP compliance (21 CFR Part 58) and electronic records compliance (21 CFR Part 11). The organization is staffed with RQAP-GLP credentialed auditors providing regulatory oversight and guidance.

Animal Welfare

The company is committed to the 3Rs principle (replacement, reduction, and refinement) with extensive staff training to ensure quality of life for laboratory animals and study success.

Certifications

AuthorityIdentifierSource
FDA21 CFR Part 58View
FDA21 CFR Part 11View

Locations

  • Muskegon

    Muskegon · Michigan · United States

  • Norton Shores

    Norton Shores · Michigan · United States

  • Portage

    Portage · Michigan · United States

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