Quality Assurance / GLP Compliance Monitoring Services
We are Quality Reviews, Inc., a corporation organized and operated in West Virginia. QRI is a multi-faceted corporation specializing in the physical, biological and social sciences.
QRI was incorporated in 1990 due to the merger of SchellWare (founded in 1977), a computer/media/consulting firm, the leadership/management expertise of Robert W. Schellhaas, Ph.D., and the scientific consulting services of Linda J. Plankenhorn.
QRI has the resources necessary to provide a full range of quality assurance/regulatory compliance support services as well as a variety of technical document services to government, private-sector and academic organizations conducting biomedical research.
Our clients include a number of Fortune 500 companies.
QRI is located near the crossroads of Interstates 81 and 70, just south of Hagerstown, MD. We are 1-1/2 hours from Washington DC and Baltimore, 3 hours from Philadelphia or Pittsburgh, 4-1/2 hours from the New York/New Jersey corridor and 6 hours from Research Triangle Park, NC.
Our senior scientific staff includes regulatory compliance specialists with over 30 years of cumulative experience in conducting, monitoring, quick-turnaround reporting and evaluating studies designed to comply with the EPA testing guidelines established under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Toxic Substance Control Act (TSCA) or the requirements of IND and NDA submissions to the FDA. Our staff also has extensive knowledge of international regulations including the requirements for registration of drugs in Japan (MOHW), Japan's testing guidelines for the safe use of agrichemicals (MAFF) and the OECD guidelines for testing of chemicals.
We offer experience with a wide range of testing protocols (prechronic, chronic and carcinogenicity studies; reproduction and teratology evaluations; mutagenicity and cytogenicity studies; avian, wild mammal, and aquatic toxicity tests) and specialty areas (histology, pathology, laboratory animal medicine, clinical pathology and analytical chemistry).
Through our behavioral division, we offer leadership and management consultation and workshops, based upon over twenty years of experience.
Our computer technology services, based upon over fifteen years of experience, offers a broad range of services.
PRELIMINARY GLP COMPLIANCE ASSESSMENTS for agrichemical or pharmaceutical clients interested in verifying GLP compliance status at contract facilities prior to placement of studies.
IN-LIFE STUDY MONITORING for organizations that do not have a functioning QA unit or for those that require additional resources or specialized expertise.
IN-DEPTH REPORT AND RAW DATA AUDITS of completed studies to verify compliance with GLP regulations or to evaluate adequacy of study design and conduct.
INDEPENDENT THIRD-PARTY AUDITS of studies intended for FDA or EPA submission for organizations that desire independent verification of regulatory compliance.
DEVELOPMENT AND MAINTENANCE OF QUALITY ASSURANCE PROGRAMS for organizations wanting to develop capabilities for the conduct of GLP-compliant studies. These services include GLP training programs to provide your staff with a full understanding of the regulatory guideline requirements.
PRE-INSPECTION ASSISTANCE for organizations facing FDA or EPA inspections. Having recently assisted laboratories with the regulatory inspection process, we can offer an honest assessment of current compliance status and assistance in the implementation of remedial action programs prior to inspection.
DEVELOPMENT OF STANDARD OPERATING PROCEDURES AND STUDY PROTOCOLS or evaluation and revision of current SOPs and protocols to assure compliance with GLPs and other regulatory requirements.
OCCASIONAL QUALITY ASSURANCE SUPPORT by trained auditors and inspectors. These services are available on an occasional overload basis or to provide the extra part-time person that your budget can't afford.