Barry Rothman Has Joined Lachman Consultant Services, Inc. as Manager
WESTBURY, N.Y., Dec. 1, 2011 /PRNewswire/ -- We are pleased to announce that Barry Rothman has joined Lachman Consultants as Manager, Compliance Practice. Barry comes to Lachman having recently retired from FDA after a thirty-seven year career, most recently serving as Acting Director, Division of Good Manufacturing Practice Assessment of the Office of Manufacturing and Product Quality Office of Compliance/CDER. In this position, Barry was responsible for directing and managing FDA's NDA/ANDA Pre-approval Compliance Evaluation Program, and the Biotech Manufacturing Branch that reviewed chemistry, manufacturing and control (CMC) sections of BLAs and performed pre-license and pre-approval inspections. Barry previously served FDA as Chief of the Manufacturing Assessment and Preapproval Compliance Branch, and as a Senior Compliance Official. In this latter position, he was involved with the approval and resolution of complex regulatory actions involving GMP, product quality and data integrity violations, including Warning Letters, Seizures, Consent Decrees of Permanent Injunctions, Import Alerts, and Application Integrity Policy. In addition to his expertise in general GMP requirements, he specialized in stability programs, packaging/labeling control, Supply Chain, Cold-Chain Management, and was an FDA/ORA national training expert. Early in Barry's career he served seventeen years as a Field Investigator. Barry is the recipient of numerous honor awards and commendations.
For more than 30 years, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.
CONTACT: Michele Sinoway, Phone: (516) 222-6222, [email protected]
SOURCE Lachman Consultant Services, Inc.
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