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Nucro-Technics

Canada's largest privately owned CRO specializing in GMP and GLP testing for 50+ years.

Canada's largest privately owned CRO specializing in GMP and GLP testing for pharmaceutical, biologic, and medical device companies. Offers analytical chemistry, microbiology, toxicology, bioanalytical, and genetic toxicology services with over 50 years of experience. Headquartered in Toronto, Canada.

Phases

Services

Technical specifications & accreditations

About this organization

Nucro-Technics is a pharmaceutical Contract Research Organization (CRO) founded in 1970, operating from a 60,000 square foot state-of-the-art facility near Toronto, Canada. The organization employs more than 170 scientific support personnel with over 4,000 years of combined experience in testing both large molecule and small molecule compounds.

Services

Analytical Chemistry Testing

  • Bradford Assay
  • Nitrosamine Impurities
  • OECD 101: UV-VIS Absorption Spectra
  • USP Residual Solvents

Microbiology Testing

  • Disinfectant Efficacy Studies (GMP)
  • USP Microbial Enumeration Tests
  • USP Bacterial Endotoxin Test

Toxicology Services

  • Safety Pharmacology Studies
  • Bioassay Studies
  • USP Pyrogen Test
  • OECD 402: Acute Dermal Toxicity
  • OECD 404: Dermal Irritation/Corrosion
  • OECD 405: Acute Eye Irritation/Corrosion
  • OECD 406: Skin Sensitization
  • OECD 425: Acute Oral Toxicity
  • OECD 439: In Vitro Skin Irritation

In Vitro ADME

  • Hemolysis Assay
  • In Vitro Flocculation Assay
  • Platelet Activation Assay

Bioanalytical Services

  • Bioanalytical Sampling Techniques
  • Protein-Specific Bioanalysis

Genetic Toxicology Services

  • OECD 471: Ames Test
  • OECD 473: Mammalian Chromosomal Aberration
  • OECD 474: In vivo Mammalian Micronucleus
  • OECD 475: Bone Marrow Chromosomal Aberration
  • OECD 487: In Vitro Mammalian Cell Micronucleus
  • OECD 490: Mouse Lymphoma Test
  • In Vitro Mammalian Cell Mutation Assay for Nitrosamines

GMP & GLP Cytotoxicity Assays

  • ISO 10993-5: Tests for in vitro Cytotoxicity
  • LDH Cytotoxicity
  • NRU Cytotoxicity Test
  • XTT Cytotoxicity Test

Photomutagenicity and Phototoxicity Assays

  • In Vitro 3T3 NRU Phototoxicity Test
  • Cleaved Caspase-3 Test

Additional Services

  • Mass Spectrometry Services
  • Medical Device Testing
  • Stability Storage/Testing
  • QA/QC Consulting
  • NHP Consulting & Testing Services
  • Regulatory Affairs Consulting
  • Cosmetic Ingredient Reviews
  • Medical Marijuana & Medical Cannabis Testing

Regulatory Compliance

Nucro-Technics is inspected by and in compliance with:

  • US FDA (Food and Drug Administration)
  • Health Canada
  • Standards Council of Canada to the OECD GLP Standard
  • ISO 9001:2015

The organization serves a diverse client base ranging from small virtual companies fulfilling GLP IND requirements to Fortune 500 pharmaceutical companies meeting GMP product release and stability testing obligations.

Certifications

AuthorityIdentifierSource
Standards Council of CanadaOECD GLP StandardView
ISOISO 9001:2015View

Locations

  • Headquarters

    Toronto · Ontario · Canada

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