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Regulatory Resources

Nelson Labs Global Headquarters in Salt Lake City, Utah, USA

Nelson Labs facility in Salt Lake City, Utah, USA is U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited.

Certifications Packet

Packet includes:

  • ISO 17025 Accreditation
  • ISO 17025 Accreditation Scope
  • FDA Registration (Device)
  • Generic Drug User Fee Act Amendment (Self Identification Validation Certificate)
  • FDA Registration (Drug)
  • GTP (Good Tissue Practice) Certificate
  • EU GMP Certificate of Compliance
  • EU GMP Certificate Scope
  • DEA Certificate
  • State of Utah, Department of Commerce Certificate
  • TGA GMP Certificate of Compliance


North American Laboratories Certifications

Bozeman, Montana, USA

Itasca, Illinois, USA

Ontario, California, USA

Mexico City, Mexico

Nelson Labs Europe Certifications

Nelson Labs Europe provides comprehensive analytical services for all stages of product development, from concept to final product. The scientific approach of our experienced staff provides comprehensive techniques for the pharmaceutical and biotechnology industries, including method development and validation, stability studies, extractables and leachables, microbiological and bioanalytical services.

Our facilities and dedicated laboratory management can offer the highest quality of work in compliance with GMP, GLP, OECD, and ISO 17025. With decades of experience, our team will collaborate with you as an extension of your company to facilitate drug and device development, achieve product safety, comply with regulations, as well as maintain the highest levels of laboratory quality control.

Nelson Labs Europe is recognized for the analysis and control of medicinal products, narcotics, and hormones by the Belgian Ministry of Health and has an in-house QP. This recognition means EU-GMP compliance.

Nelson Labs Europe laboratory is:

  • GMP inspected and recognized by the Belgian Federal Agency for Medicinal and Healthcare Products (FAMHP)
  • GLP certified by the Scientific Institute of Public Health (IPH) (Identification number: T02)
  • FDA registered (FDA Establishment Identifier (FEI): 3005742674) and
  • ISO 17025 accredited by BELAC (Identification number: 363-TEST)