Our Accreditations & Certifications

CERTIFICATIONS

Minneapolis, MINNESOTA USA

400 Highway 169 South, Minneapolis, MN – Expires MAY 6, 2025


ISO 9001:2015 Certification

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CHESHIRE, UNITED KINGDOM

Techspace One, Keckwick Lane, Daresbury, Warrington – Expires SEP 2, 2026


ISO 9001:2015 Certification

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SELBY, UNITED KINGDOM

Unit 9 & 11, Abbey Court, Benedict Drive, Selby – Expires JUN 1, 2027


ISO 9001:2015 Certification

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Diest, Belgium

Heggestraat 10, Diest – Does not expire


Good Laboratory Practice (GLP) Certification

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Lyon, France

115 Chemin de l’Islon, CHASSE-sur-RHÔNE – Does not expire


Good Laboratory Practice (GLP) Certification

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INFORMATION SECURITY MANAGEMENT

6750 Wales Rd, Northwood, OH – Expires OCT 31, 2025


ISO/IEC 27001:2013 Certification

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Atlanta, Georgia USA

1265 Kennestone Circle, Marietta, GA – Does not expire


EMA Certificate of GMP Compliance (Sterility)

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Saint Paul, Minnesota USA

2540 Executive Dr, Saint Paul, MN – Does not expire


EMA Certificate of GMP Compliance

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Atlanta, Georgia USA

1265 Kennestone Circle, Marietta, GA – Expires FEB 1, 2026


International Safe Transit Association (ISTA) Membership

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ACCREDITATIONS

NORTHWOOD, OHIO USA

6750 Wales Rd, Northwood, OH – Expires MAR 9, 2026


ISO/IEC 17025:2017 Accreditation

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NORTHWOOD, OHIO USA

6750 Wales Rd, Northwood, OH – Expires MAR 9, 2026


FDA ASCA Program Accreditation for Biocompatibility Testing

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MINNEAPOLIS, Minnesota USA

8945 Evergreen, Minneapolis, MN – Expires MAR 9, 2026


ISO/IEC 17025:2017 Accreditation

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Saint Paul, Minnesota USA

2520 Pilot Knob Rd., Mendota Heights, MN – Expires MAY 31, 2026


ISO/IEC 17025:2017

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Saint Paul, Minnesota USA

2540 Executive Dr., St. Paul, MN – Expires APR 30, 2025 (BIOLOGICAL TESTING)


ISO/IEC 17025:2017

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Atlanta, Georgia USA

1265 Kennestone Cir, Marietta, GA – Expires APR 30, 2025 (BIOLOGICAL TESTING)


ISO/IEC 17025:2017

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Atlanta, Georgia USA

1265 Kennestone Cir, Marietta, GA – Expires APR 30, 2025 (CHEMISTRY TESTING)


ISO/IEC 17025:2017

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IRVINE, CALIFORNIA USA

9 Morgan, Irvine CA – Expires MAR 9, 2026


ISO/IEC 17025:2017 Accreditation

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Obernburg, Germany

Industrie Center Obernburg – Certificate does not expire


DIN EN ISO/IEC 17025:2018 Accreditation

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Lyon, France

115 ch de l’Islon, CHASSE SUR RHONE – Expires DEC 31, 2027


NF EN ISO/IEC 17025:2017 Accreditation

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Saint Paul, Minnesota USA

Saint Paul, MN location – Expires OCT 3, 2024


American Association of Tissue Banks (AATB)

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Saint Paul, Minnesota USA

2540 Executive Dr., Saint Paul, MN – Does not expire


State of Maryland Tissue Bank Permit

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Saint Paul, Minnesota USA

2540 Executive Dr., Saint Paul, MN – Expires JUN 1, 2025


State of New York Provisional License for Tissue Banks

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REGISTRATIONS

northwood, ohio usa

NAMSA is registered with the CDER and CBER divisions of the FDA. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820 as well as inspections by CDER under 21 CFR 211.


FDA Registration #1521876

IRVINE, CALIFORNIA USA

NAMSA is registered with the CDER and CBER divisions of the FDA. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820 as well as inspections by CDER under 21 CFR 211.


FDA Registration #2020640

Atlanta, Georgia USA

NAMSA is registered with the CDER and CBER divisions of the FDA. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820 as well as inspections by CDER under 21 CFR 211.


FDA Registration #1000511606

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Saint Paul, Minnesota USA

NAMSA is registered with the CDER and CBER divisions of the FDA. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820 as well as inspections by CDER under 21 CFR 211.


FDA Registration #3002199759

US DEA REGISTRATION

Registration numbers are confidential. Registered at state and federal level.

Quality Policy

NAMSA delivers high quality, competitive, on-time medical research services. We help clients meet regulatory requirements and exceed their expectations while continuously improving.
To successfully and consistently deliver our quality policy for global clinical research organization (CRO) clients, we adhere to the following procedures, requirements and certifications:

  • NAMSA is certified to ISO 9001:2015, and is accredited to ISO/IEC 17025:2017.
  • NAMSA is committed, through our internal audit and management review processes, to ensuring continued compliance with all relevant regulatory and statutory requirements including but not limited to ISO 13485:2016, 21 CFR Part 211, and 21 CFR Part 820.
  • NAMSA is committed to the highest level of impartiality for all activities and dealings with our clients and other interested parties through its portfolio of services.
  • We operate with full accreditation by AAALAC International.
  • We follow U.S. Department of Agriculture (USDA) regulations.

Protocols and Procedures

  • All samples submitted to NAMSA are tested according to established written standard operating procedures, or specific protocols or study plans, as appropriate.
  • Samples are assigned a sequential lab control number which is used on all associated raw data sheets, log books, laboratory notebooks, and NAMSA laboratory reports.
  • Traceability and test status are maintained and tracked through these control numbers and systems of physical segregation.
  • Strict laboratory quality guidelines are followed to assure valid data.
  • Each step of laboratory operations is carefully controlled to assure accurate and reliable testing programs.
  • Original data are recorded in ink on signed, dated record forms or notebooks and are approved by supervisory personnel.
  • Upon completion of a study, all data are stored in a central file in permanent archives.
  • Clients are promptly notified of adverse test results by telephone or facsimile, without charge.
  • Fees listed for each test include:
    • One copy of the final report to a designated individual
    • One copy of the final report and supporting data to NAMSA archives
    • One invoice to a designated individual or department

Auditing and Review

NAMSA has a robust internal audit program including process-based audits, facility audits, and testing-based audits from an independent quality assurance unit.

  • Members of NAMSA’s staff are selected and trained for specific job functions.
  • Laboratory equipment is entered in a central calibration and maintenance program for routine calibration.
  • Laboratory functions are audited by NAMSA’s quality assurance department staff.
  • Independent and regulatory auditors routinely visit NAMSA to verify compliance to quality system standards.
  • Performance of routine tests is monitored by periodic check samples and statistical process control.