Anand Akerkar, Ph.D.:

Since 1964, he has held several senior management positions at Ciba Giegy, Becton Dickinson Technicon Corp. He also taught at New York University Medical School. Dr. Akerkar has consulted to the industry since 1986 and has been involved in Strategic Management Issues and strategic planning. He has worked also with companies in setting up Quality Systems. TQM training, and GMP related matters. In addition, he has been an invited speaker at several national and international congresses. He has published extensively. Dr. Akerkar is Scientific Advisor to U.S. Congressman Benjamin Gilman and is a member of numerous professional societies

Alan Schwartz:

Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the agency in 1978 to start his consulting career. He has traveled extensively, worldwide, serving companies on management issues, strategic planning as well as FDA requirements. He has been guest speaker at professional meetings on 510 (k) Strategic, GMP and ISO implementation. Mr. Schwartz has had numerous articles published o Quality Assurance and Regulatory Affairs and has been an invited guest speaker at medial industry professional meetings worldwide.

Charles Batemen

Charlie Bateman has 25 years experience in medical sales and marketing. Mr. Bateman has held Management positions with Biomedical Labs, Baxter, Becton Dickinson and Difco Laboratories. His experience in sales and marketing covers a full range of products from medical surgical, pharmaceuticals, labs services to immunology and microbiology in the clinical and industrial segments of the medical in- vitro and in vivo markets. He also brings the experience of over 15 years of marketing/selling to and managing National Accounts. This experience has provided Charlie the understanding on how to position a company and its products, in creating a presence, and marketing/selling "the package" which is critical in today's environment. In all his management positions Charlie has been involved in strategic planning & implementation for market and business plans as well as defining strategic partnerships.

Tom Bouchard:

Mr. Bouchard has worked with several manufacturing companies setting and maintaining their Quality System programs, obtaining ISO certification and maintaining their compliance to the various Federal, State, and Local government regulations. Tom was formerly a Field Investigator with the U.S. Food Administration. He has over 25 years of Quality Assurance experiences. Tom has obtained the International Certification of Lead Assessor for the ISO standard.

Milton N. Beneke, Jr.:

Mr. Beneke has been GMP & Clinical Trial Specialist with our organization for three years. His consulting duties include traveling worldwide to conduct audits for the medical device and pharmaceutical industries with emphases on monitoring of clinical trials, GMP compliance assistance and preparation of market approval submissions. He has also successfully passed the ISO lead assurance-training course. Prior to that he worked as a Clinical Trial & GMP Monitor for Chathamborough Research Group. Mr. Beneke has over 19 years of experience as an FDA Field Investigator.

Susan D. Goldstein-Falk:

Ms. Goldstein-Falk has traveled worldwide consulting with companies regarding GMP Compliance, performing GMP audits, implementation of Quality System Manuals and PMAs. She has achieved a high level of integrity with the FDA and has a 100% success rate in obtaining 510 (k) approval usually within the average FDA review time. Ms. Goldstein-Falk was previously Manager of Corporate Compliance for Delmed, Inc. In addition, she was a Consumer Safety Officer/Investigator for the FDA from 1983 - 1986.

Bob Kanter

Bob Kanter brings more than twenty years of professional experience in all phases of product development and market introduction in the bioscience industry. His expertise includes all aspects of In Vitro Diagnostics development encompassing project definition, management and the product development process. As a Vice President with Bayer, Bob was responsible for the R and D activities of multi-disciplinary teams developing reagents, software, and biologicals as well as complete user documentation to assure global regulatory compliance. Bob has had extensive international experience, particularly in developing products for off-shore manufacturing; and in the organization of cooperative research and trial activities in France, Germany, the U. K., Italy, Scandinavia, Japan and China. He is particularly skilled in the international regulatory requirements for the design control and training elements needed to achieve ISO 9001certification. Bob holds advanced degrees from Long Island University and New York University as well as a Certificate in Advanced Management.

Carol Ann Kotula:

Ms. Kotula was an FDA Field Investigator for eight years and an independent consultant for one year. Her areas of expertise include preparation and submission of 510(k)s, setting up Quality System Manuals, troubleshooting FDA Regulatory and Quality Assurance problems and GMP and QA employee training. Her FDA Troubleshooting in the GMP has been recognized worldwide. She has set up over 150 Quality System programs worldwide and has been accepted as an expert by the FDA for Third Party Certifications.

Mohan Ratanchandani

Mohan Ratanchandani brings 22 years of experience in quality, manufacturing and Design to the organization. His long-term experience includes government and commercial contracts involving Automobile Gears Manufacturing and the Optical and Medical Device Industry. Mohan is a New York State registered P.E. (professional engineer). His credentials include CQE (certified quality engineer), CRE (certified reliability engineer, and Lead Auditor to quality system. Mohan has obtained the International Certification of Lead Assessor for the ISO standard.