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NorthernBio

Preclinical CRO specializing in GLP-compliant in vivo safety assessment and bioanalysis.

Michigan-based preclinical CRO specializing in GLP-compliant in vivo safety assessment, targeted drug delivery, molecular biology, and ligand binding bioanalysis across neuroscience, ophthalmology, cardiovascular, metabolic, and rare disease indications. Headquartered in Muskegon, United States.

Phases

Indications / Therapeutic Areas

Services

Technical specifications & accreditations

Accreditations

About this organization

NorthernBio is a preclinical contract research organization headquartered in Michigan with three GLP-compliant facilities dedicated to supporting drug and medical device development. The organization specializes in non-GLP and GLP-compliant in vivo safety assessment solutions using advanced surgical techniques, with particular expertise in targeted drug delivery and molecular biology.

Service Areas:

  • In Vivo Research: GLP and non-GLP safety assessment, surgical models, large animal and rodent studies
  • Bioanalytical Services: Advanced molecular biological techniques and ligand binding assays
  • Therapeutic Expertise: Neuroscience, ophthalmology, cardiovascular, metabolic, and rare disease research
  • Regulatory Support: Customized preclinical study design to facilitate regulatory approval

Facilities:

  • Muskegon facility: Large animal species research
  • Norton Shores facility: Rodent and ophthalmology research
  • Portage facility: Molecular biology and bioanalysis supporting preclinical and clinical trials

Quality & Compliance: NorthernBio maintains an independent quality assurance unit monitoring 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), with RQAP-GLP credentialed auditors providing regulatory oversight. The organization is committed to the 3Rs principle (replacement, reduction, refinement) in animal welfare.

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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