Since 1968, Oriel STAT A MATRIX, A Validant Company, has been a global leader in training and consulting for business process improvement, regulatory compliance, and quality management systems.
Today, our primary focus is supporting medical device, pharmaceutical, and biologics manufacturers. We help Life Sciences companies comply with FDA and international regulations, prepare product submissions, and make their processes more effective and efficient.
Our greatest strength is our team of dynamic consultants and trainers. They have extensive experience in their specialty fields, and many of them were senior-level professionals before joining us. All have spent considerable time in the field helping to design and implement regulatory programs, corporate strategies, leadership development programs, improvement efforts, and training materials. Their industry experience—they handled the same issues you struggle with— drives the development of new training and improvement tools to help your organization meet these tough challenges.
Our ultimate goal: Give our customers a significant return on their investment with us by providing them the skills and knowledge they need to achieve compliance, improve their processes, and produce safe, effective products.
Oriel STAT A MATRIX is headquartered in Union, New Jersey. We maintain offices in 18 countries, and we have team members based in more than 100 countries.
For more information about Oriel STAT A MATRIX please visit www.orielstat.com or call 800.472.6477.
Company’s Keywords:
fda strategic planning, iso 13485, qsr quality system implementation, 510 & pma submissions, process validation, fda483 review & warning letter response, lean six sigma, curriculum development & ra, qa training, risk management, capa, eu mdr, eu ivdr, mdsap, quality system audits, samd, nonproduct software validation
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