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Mr. Kim Nitahara

Principal Consultant and CEO

Mr. Kim Nitahara is the cofounder and Chief Executive Officer of META Solutions. Since its inception in 1987, the company has performed needs analyses, technical consulting, computer system consulting, and computer software validation services for more than two hundred pharmaceutical and biotechnology companies throughout North America, Europe and Asia.

Mr. Nitahara was the Director of Business Development at Medical Development Systems, Inc. where he was responsible for the development and implementation of the Marketing Plan for a software product designed for the management of clinical trials data and supporting activities (CLINTROL). Mr. Nitahara has held the position of R&D Administrator at Berlex Laboratories, Inc., a subsidiary of Schering AG, where he was responsible for the development and implementation of computerized systems for project management of pharmaceutical R&D activities and systems for the automated indexing and retrieval of research documentation. While he was at Berlex, he also served as the Toxicology & Preclinical Development Coordinator, and was a Regulatory Compliance Associate and Manager of the GLP Quality Assurance Unit in the Drug Regulatory Affairs Department. Kim also gained significant experience in preclinical toxicology safety evaluation testing and GLP quality assurance monitoring and auditing during his employment at Bio/dynamics, Inc., a large contract toxicology firm.

Mr. Nitahara has extensive experience in pharmaceutical computer systems design and development, and is considered to be an authority on electronic document management, imaging technology, electronic submissions and computer system validation. He was a co-author of the FDA/industry/academia "Red Apple Workshop" collaboration on "Computerized Data Systems for Nonclinical Safety Assessments: Current Concepts and Quality Assurance". Mr. Nitahara was the founder and Editor of a monthly publication entitled, "The Compliance Advisor" which includes detailed reviews of actual FDA inspection results and provides practical advice on how a company should prepare for a regulatory inspection.

Mr. Nitahara was been internationally recognized as a presenter or chairman of more than 70 industry meetings and workshops sponsored by such industry organizations as the Drug Information Association, (DIA), Society of Quality Assurance (SQA), Society of Clinical Data Management (SCDM), and the Pharmaceutical Manufacturers Association (PMA; now PhRMA). At the DIA Annual Meeting in 1995, Mr. Nitahara received the Outstanding Service Award for his years of service to the DIA. His professional affiliations include the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), the Society of Quality Assurance (SQA), the Association for Information and Image Management (AIIM), and the Society of Toxicology, Mid-Atlantic Chapter (MAST). He was the National Secretary of the Society of Quality Assurance and a member of its Board of Directors from 1989 to 1994.

Mr. Nitahara has a Masters of Business Administration from Fairleigh Dickinson University and a Bachelor of Arts from Rutgers University. He also received the designation of "Master of Information Technologies" from the Association for Information and Image Management International.

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META Solutions, Inc.
63 Grove Street, Somerville, New Jersey 08876
1.866.METASOL | P 908.791.1900 | F 908.791.9977