Your cart is currently empty!
Our Accreditations & Certifications

CERTIFICATIONS
Minneapolis, MINNESOTA USA
400 Highway 169 South, Minneapolis, MN – Expires MAY 6, 2025
ISO 9001:2015 Certification
DownloadCHESHIRE, UNITED KINGDOM
Techspace One, Keckwick Lane, Daresbury, Warrington – Expires SEP 2, 2026
ISO 9001:2015 Certification
DownloadSELBY, UNITED KINGDOM
Unit 9 & 11, Abbey Court, Benedict Drive, Selby – Expires JUN 1, 2027
ISO 9001:2015 Certification
DownloadDiest, Belgium
Heggestraat 10, Diest – Does not expire
Good Laboratory Practice (GLP) Certification
DownloadLyon, France
115 Chemin de l’Islon, CHASSE-sur-RHÔNE – Does not expire
Good Laboratory Practice (GLP) Certification
DownloadINFORMATION SECURITY MANAGEMENT
6750 Wales Rd, Northwood, OH – Expires OCT 31, 2025
ISO/IEC 27001:2013 Certification
DownloadAtlanta, Georgia USA
1265 Kennestone Circle, Marietta, GA – Does not expire
EMA Certificate of GMP Compliance (Sterility)
DownloadSaint Paul, Minnesota USA
2540 Executive Dr, Saint Paul, MN – Does not expire
EMA Certificate of GMP Compliance
DownloadAtlanta, Georgia USA
1265 Kennestone Circle, Marietta, GA – Expires FEB 1, 2026
International Safe Transit Association (ISTA) Membership
DownloadACCREDITATIONS
NORTHWOOD, OHIO USA
6750 Wales Rd, Northwood, OH – Expires MAR 9, 2026
ISO/IEC 17025:2017 Accreditation
DownloadNORTHWOOD, OHIO USA
6750 Wales Rd, Northwood, OH – Expires MAR 9, 2026
FDA ASCA Program Accreditation for Biocompatibility Testing
DownloadMINNEAPOLIS, Minnesota USA
8945 Evergreen, Minneapolis, MN – Expires MAR 9, 2026
ISO/IEC 17025:2017 Accreditation
DownloadSaint Paul, Minnesota USA
2520 Pilot Knob Rd., Mendota Heights, MN – Expires MAY 31, 2026
ISO/IEC 17025:2017
DownloadSaint Paul, Minnesota USA
2540 Executive Dr., St. Paul, MN – Expires APR 30, 2025 (BIOLOGICAL TESTING)
ISO/IEC 17025:2017
DownloadAtlanta, Georgia USA
1265 Kennestone Cir, Marietta, GA – Expires APR 30, 2025 (BIOLOGICAL TESTING)
ISO/IEC 17025:2017
DownloadAtlanta, Georgia USA
1265 Kennestone Cir, Marietta, GA – Expires APR 30, 2025 (CHEMISTRY TESTING)
ISO/IEC 17025:2017
DownloadIRVINE, CALIFORNIA USA
9 Morgan, Irvine CA – Expires MAR 9, 2026
ISO/IEC 17025:2017 Accreditation
DownloadObernburg, Germany
Industrie Center Obernburg – Certificate does not expire
DIN EN ISO/IEC 17025:2018 Accreditation
DownloadLyon, France
115 ch de l’Islon, CHASSE SUR RHONE – Expires DEC 31, 2027
NF EN ISO/IEC 17025:2017 Accreditation
DownloadSaint Paul, Minnesota USA
Saint Paul, MN location – Expires OCT 3, 2024
American Association of Tissue Banks (AATB)
DownloadSaint Paul, Minnesota USA
2540 Executive Dr., Saint Paul, MN – Does not expire
State of Maryland Tissue Bank Permit
DownloadSaint Paul, Minnesota USA
2540 Executive Dr., Saint Paul, MN – Expires JUN 1, 2025
State of New York Provisional License for Tissue Banks
DownloadREGISTRATIONS
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
DownloadSaint 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.