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Ken Block Consulting is a global regulatory consulting firm with offices in Europe, Japan, and the United States, specializing in providing comprehensive services in regulatory strategy, quality systems, FDA submissions, audits, inspections, validation, compliance remediation, risk management, and training. With a strong reputation and a track record of successful FDA submission projects and quality system projects, Ken Block Consulting is known for its expertise in breakthrough device designations. The company has published articles, delivered invited speeches, and participated in panel sessions, establishing itself as a trusted resource in the industry.Generated from the website