Certifications

MRIGlobal maintains all necessary licenses and certifications to conduct safe, defensible studies on a host of diverse materials, from pharmaceuticals and explosives to chemical and biological agents.

International Organization for Standardization (ISO)

BSI Management Systems, an International Organization for Standardization (ISO) registrar, has granted ISO 9001:2015 certification to most MRIGlobal physical locations operating under our quality management system (Headquarters, North Kansas City, Charlottesville, and Gaithersburg). This certification recognizes MRIGlobal’s ability to consistently provide products and services that meet client and applicable regulatory requirements.

Our Gaithersburg facility is also ISO 17025 accredited and the Kansas City Facilities have both CLIA and soon  ISO 17025 accredited laboratory space.

Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

The FDA, EPA, and numerous clients have found MRIGlobal compliant with regulations governing GLP (FDA, EPA-FIFRA, EPA-TSCA) and GMP.

Food and Drug Administration (FDA)

Drug Establishment Registration

Drug Master File

Environmental Protection Agency (EPA)

FIFRA Establishment

United States Department of Agriculture (USDA)

For all species except rats and mice

Public Health Service (PHS) Animal Welfare Assurance

For PHS funding only

Human Subjects:  Office for Human Research Protection (OHRP)

Nuclear Regulatory Commission (NRC)

Drug Enforcement Administration (DEA)—Controlled Substance Registration

Schedules 1-5

Centers for Disease Control and Prevention (CDC)

Facility Registration for Transferring or Receiving Select Agents

CBRNE/CWMD Chemical Agent Operations

Provisioning Agreement

USDA Animal and Plant Health Inspection Services (APHIS)

Multiple permits for select agents and toxins

Centers for Medicare and Medicaid Services (CMS)

Clinical Laboratory Improvement Act/Amendment (CLIA)

College of American Pathologists (CAP)

Full accreditation

Florida—Agency for Health Care Administration (AHCA)

ATF Explosive Materials Permit

> 70 staff with possessor licenses

Defense Security Service (DSS)

NISPOM Accredited

Methods

CBRNE Tech Index scientists at MRIGlobal frequently perform standardized and custom evaluations for a wide range of customers. Evaluation methods can range from those requiring published MIL-STD, ASTM, or EPA regulatory compliance testing, to highly customized set-ups and target lists for unique clients. As part of any testing and evaluation program, MRIGlobal will deliver a detailed test plan for approval by the client long before actual testing begins. Test plans contain detailed test matrices, references to applicable ASTM, EPA, and other nationally recognized methods, leverage existing internal methods and SOPs, and help walk our clients through the entire evaluation process at the level of detail desired. Many clients wish to have in-depth step-by-step procedures to be witnessed at all times by multiple staff, others simply wish to have an overview of the general methods and schedules. 

The less thought of, yet typically most important, piece of the puzzle is often the human factors portion of an evaluation. Our diverse staff includes a variety of skill, education, and experience levels that all uniquely contribute to a product evaluation by providing specific end-user viewpoints. Through our many years of experience, we have both internal and external contacts in virtually all areas of CBRNE equipment ranging from local first responders and crime laboratories to military personnel and federal agents.