🏆 Quality Assurance & Standards

Regulatory Compliance & Quality Standards

Explore our certifications and the standards that guide our quality and environmental management.

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ISO 9001:2015 Quality Management (QMS/023902)
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ISO/IEC 17025:2017 Testing & Calibration (EU/261363)
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ISO 17034:2016 Reference Material Producer (EU/261361)
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ISO 14001:2015 Environmental Management (EMS/261358)

International Certifications & Accreditations

Our certified management systems provide a clear framework for the work behind our chemical products and services.

ISO 9001:2015

Quality Management System

Optimum Certifications Inc. / UK SAF Accredited

A certified Quality Management System covering research, development, production, characterization, storage, and supply of pharmaceutical, chemical, and analytical reference materials.

  • Active Pharmaceutical Ingredients (APIs) & Pharmaceutical Reference Standards
  • Process-Related & Degradation-Related Impurities synthesis
  • Drug Metabolites & Their Conjugates, Stable Isotope-Labelled Compounds
  • Associated Laboratory, Research, Analytical & Contract Service Activities
ISO 9001:2015 (Compliance)

Quality Management System - Certificate of Compliance

Optimum Certifications Inc. / UK SAF Accredited

This ISO 9001:2015 certificate confirms conformity across facility operations, synthesis processes, and quality testing at the Brantford, Ontario facility.

  • Conformity assessment by Optimum Certifications Inc.
  • Production & packaging of chemical & analytical reference materials
  • Full compliance with international quality management requirements
  • Online verification available at www.ocicert.com
ISO/IEC 17025:2017

Testing and Calibration Laboratories

Optimum Certifications Inc. / UK SAF Accredited

Certification of laboratory competence for NIST-traceable and certified reference materials, spectrophotometry standards, and multi-technique impurity testing.

  • NIST Traceable & Certified Reference Materials (CRM)
  • Spectrophotometry Standards & Pesticide Standards
  • GC Reg. Standards, Cation & Anion Standards
  • Pharmacopoeial, Non-Pharmacopoeial and Impurity Standards
ISO 17034:2016

Competence of Reference Material Producers

Optimum Certifications Inc. / UK SAF Accredited

Accredited competence in producing and characterizing reference materials and CRMs, including property-value assignment and homogeneity and stability assessment.

  • Reference Materials & Certified Reference Materials (CRMs)
  • Process-Related & Degradation-Related Impurities & Drug Metabolites
  • Stable Isotope-Labelled Compounds & Chromatographic Solvents
  • Pharmacopoeial & Non-Pharmacopoeial Analytical Reference Materials
ISO 14001:2015

Environmental Management System

Optimum Certifications Inc. / UK SAF Accredited

A certified Environmental Management System for responsible research, handling, storage, packaging, and international supply of analytical reference chemicals.

  • Environmental management across all research & contract service operations
  • Controlled chemical storage, packaging & international supply
  • Handling of APIs, reference standards, and stable isotope compounds
  • Sustainable environmental compliance verified under UK SAF accreditation
Third-Party Verification

Need Audit Support or Batch Documentation?

Contact our team to discuss audit support, site visits, Drug Master File access, or batch-specific Certificate of Analysis documentation.