Pharmaceutical Consulting Services

With over 24 years of pharmaceutical development experience, Clifford Siporin, Ph.D., President of Greystone Pharmaceutical Consulting, is providing a wide range of clinical and regulatory services for the pharmaceutical, medical device and biotechnology industry. With a network of equally qualified professionals, Dr. Siporin now provides executive experience and operational management to the industry, including,

Management of complete clinical programs, including: protocol and CRF design, investigator identification, clinical monitoring and auditing, data base development, statistical analysis of safety and efficacy, preparation of the final clinical report and publication manuscriptm, GCP, GMP and GLP auditing and training of new and existing clinical and manufacturing facilities, U.S. and International
Regulatory services, including preparation of complete INDs/IDEs, 510k and NDAs/SNDAs/PLAs, regulatory strategy development
Scientific/Medical writing for regulatory submissions and journal manuscripts
Identification of monitors, manufacturing, pre-clinical and clinical auditors and a wide range of technical professionals for assignments by the sponsor
Diligence review of regulatory submissions and study summaries

Prior to forming his own consulting firm, Dr. Siporin served as Vice President Drug Development, G.D. Searle. In this position, he had responsibility for all phases of development of pharmaceuticals sourced outside the company. He was successful in identifying, evaluating and recommending new products along with the business opportunities these products represent. Prior to his success at Searle, Dr. Siporin held Director positions in International Operations and in R & D at Warner Lambert/Parke-Davis in both New Jersey and Michigan. His experience allowed him to implement a development process, which is known as the "Product Champion" concept of drug development. Dr. Siporin has obtained extensive quality control and manufacturing experience at Pfizer Inc. and International Drug Development experience at Pfizer International's Medical and Marketing Division. He is an expert witness and has given advice to attorneys and testimony in Federal Court on technical pharmaceutical and scientific issues.

His successful career spans all phases of development of antibacterial, antifungal, antiviral and anticancer products, NSAIDS, gastrointestinal, cardiovascular, dermatological, endocrine products and a range of other pharmaceuticals and biotechnology products and devices.

Dr. Siporin earned the Ph.D. at the University of Dayton in 1976 in Microbiology, is a fellow in the American Academy of Microbiology, has published an invited chapter for the Encyclopedia of Microbiology and for Annual Reviews of Microbiology, holds membership in the Licensing Executives Society, is a recognized expert in all phases of the Drug Development process and has served as Chairperson for national symposia dealing with advanced drug development. Dr. Siporin is a frequent invited speaker within the industry. He maintains a keen interest in aiding established healthcare companies, and newer ventures and the investment community, save resources while bringing new healthcare products to successful commercialization.

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