MLM Medical Labs - Germany Completes Successful FDA Assessment
MLM passed the assessment without any objections or findings. MLM’s proprietary systems provided easy access to all the detailed inquiries from the FDA and provided clear evidence of the testing data.”
MÖNCHENGLADBACH, NC, GERMANY, April 4, 2023/EINPresswire.com/ -- MLM Medical Labs, a global leader in central and specialty laboratory services, announced today the successful completion of a recent evaluation from the FDA in response to a Remote Regulatory Assessment (RRA). The RRA was triggered as part of the submission of data from two studies by MLM’s clients to the agency for regulatory review and to ensure the protection of the rights and welfare of subjects involved in FDA-regulated research. According to Nicole Jansen-Paland, Head of Quality Management for MLM Medical Labs -Germany, “MLM passed the assessment with flying colors without any objections or findings. MLM’s proprietary systems provided easy access to all the detailed inquiries from the FDA and provided clear evidence of the testing data from several years prior.” — Nicole Jansen-Paland, Head of Quality Management - Germany
Additionally, MLM has also recently received notice of continued accreditation from the College of American Pathologists (CAP), the world’s largest organization of board-certified pathologists and a leading provider of laboratory accreditation programs, for its laboratory facility in Mönchengladbach, Germany. This marks the fifth consecutive awarding of this elite accreditation.
“MLM Medical Labs is committed to delivering the highest quality, clinically-actionable information and data to our clients in the clinical trials industry,” said Dr. Stephan Voswinkel, Managing Director MLM Germany. “CAP accreditation is considered to be the most rigorous choice for lab accreditation, often exceeding the standards of state and federal agencies, and we are honored to have continued to maintain this approval.”
About MLM Medical Labs
MLM Medical Labs is an international central laboratory with locations in Europe and North America. An international team of nearly 200 highly skilled and experienced employees supports over 300 clinical trials at any given time. MLM offers a broad range of services with an assay portfolio of over 900 parameters, including central lab testing, analysis of biomarkers, histology, preclinical services, assay development, kit building, and long-term sample management and storage. The company is headquartered in Mönchengladbach, Germany (near Düsseldorf) and has laboratories in Memphis, TN, and Minneapolis, MN, USA.
For more information, please visit www.mlm-labs.com.
Michael Howell
MLM Medical Labs
+1 704-724-4320
michael.howell@mlm-labs.com
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