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      Sampled and Lighthouse Lab Services Announce Strategic Partnership

      June 25, 2025

      Sampled Renews MIA (IMP) License with MHRA Certification

      May 28, 2025

      Untangling Nature and Nurture: The HEALthy Brain and Child Development Study

      May 28, 2025

      Join us on our blog where we share our passion for unraveling the science of precision medicine, offering practical knowledge and applications from over 25 years of experience in analytical and biorepository services.

      View all our blog posts here

      Mike Sheldon

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Licenses, Permits & Accreditations

Quality drives every Sampled service, supported by globally recognised accreditations and standards.

  • Licenses, Permits & Accreditations
  • Quality Policy

Sampled maintains a comprehensive portfolio of licenses, permits, certifications, and accreditations that reflect the regulatory rigor and quality standards expected by our customers, partners, and collaborators worldwide.

These credentials validate our adherence to internationally recognized standards across sample storage, management, and advanced analytical and cellular workflows. Together, they provide confidence that samples are managed with accuracy, consistency, and regulatory alignment.

Licenses

OrganizationDescriptionRegionView PDF
CLIA License
A CLIA (Clinical Laboratory Improvement Amendments) license is required for laboratories performing tests on human specimens for health assessment, diagnosis, prevention, or treatment of disease. This ensures the accuracy, reliability, and quality of test results.
CAP Accreditation
The College of American Pathologists (CAP) sets rigorous accreditation standards for clinical laboratories and biorepositories. We hold both Laboratory and Biorepository Accreditations, demonstrating our commitment to quality, regulatory compliance, and the highest standards in specimen testing and storage.

FDA License – HCT/P Tissue Bank Registered
This license authorizes the storage and distribution of certain human tissues, in compliance with FDA regulations for tissue banking.
NYS Tissue Facility License
This license allows us to import and export tissues to and from New York State. It authorizes the handling and storage of reproductive tissues and hematopoietic progenitor cells within our biorepository.
MIA(IMP)
Issued by the MHRA (Medicines and Healthcare products Regulatory Agency), this license allows for the importation of Investigational Medicinal Products (IMPs) for human use. Also referred to as a GMP (Good Manufacturing Practice) license.
WDA (Wholesale Distributor Authorization)
Also issued by the MHRA, this license enables the procurement, storage, and distribution of medicines—licensed, unlicensed, and investigational—for human use to entities other than patients.
HFEA – Human Fertilization & Embryology Authority
Granted by the Human Fertilization and Embryology Authority (HFEA), this storage-only license is required for the transport and storage of human gametes and embryos for both clinical and research purposes.

Permits

OrganizationDescription Region View PDF
CDC Permit
This permit, issued by the Centers for Disease Control and Prevention (CDC), allows for the international import and export of human samples.
   
   

Certifications & Standards

OrganizationDescription Region View PDF
ISO 9001
ISO 9001 is a globally recognized standard for quality management systems. While optional, it reflects our dedication to continuous improvement, customer satisfaction, and operational excellence.
ISBER
As a Corporate Gold Member of ISBER (International Society for Biological and Environmental Repositories), we align with and implement ISBER’s best practices for biobanking.
GMO Approval
Approved by the UK’s Health and Safety Executive (HSE), this certification confirms that our facilities are authorized to handle genetically modified organisms (GMOs) at biosafety levels 1, 2, and contained-use level 3. All work with GMOs is pre-approved and reported to the HSE.
IATA
We adhere to International Air Transport Association (IATA) regulations for the safe and compliant transport of biological samples. All shipments—including those on dry ice—are properly labeled and packaged to ensure both regulatory compliance and the highest standards of safety.
Sampled supports ICH-aligned conditions and testing protocols for our clients. While not a certification, the International Council for Harmonisation (ICH) provides global guidelines for the development, testing, and manufacturing of quality pharmaceuticals.

Quality Policy

The Sampled Global Quality Management System and all our operations are committed to fully comply with (where applicable) current Good Manufacturing Practice (cGMP), Good Laboratory Practice (cGLP), Good Tissue Practice (cGTP), Good Distribution Practice (GDP) requirements, ISO 9001 and other applicable regulations, standards, guidelines and client agreements.

We will employ sound scientific principles and continuously strive to make our processes and services better through continuous improvement and performance excellence. Our goal is to always provide our customers with the best quality across all our analytical laboratory and biorepository services.

Find out more about our services

Are you interested in Sampled’s secure, trusted, and robust services? Get in touch today to find out how Sampled can meet all of your laboratory needs!

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Sampled
30 Knightsbridge Road
Building 3, Piscataway, NJ 08854
U.S.A

Latest news

  • Sampled and Lighthouse Lab Services Announce Strategic Partnership June 25, 2025
  • Sampled Renews MIA (IMP) License with MHRA Certification May 28, 2025
  • Untangling Nature and Nurture: The HEALthy Brain and Child Development Study May 28, 2025

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