| CASE HISTORIES: Prepared a turnaround business plan and subsequently managed implementation for a generic Rx and OTC drug manufacturer. Developed a business strategy, marketing plan and working prototype models of the first laser speed measurement device for law enforcement and laser eye surgery. Oversaw in-licensing of novel therapeutic treatment and subsequent sublicensing of value-added product. From initial concept thru GMP manufacture, developed major new OTC diagnostic products and marketed them via a leading multinational feminine hygiene products company. Performed a due diligence study and developed a strategic plan for a leading university to support a proposal to NHTSA to build a $35 million hi-tech research facility. Conceived and implemented a licensing program for a skin permeation enhancer for worldwide distribution. Developed the protocol and supervised clinical trials for two unique point-of-care medical devices. Prepared complete ISO 9000 quality system (quality plan, quality manuals, cGMPs) for medical device manufacturer bringing the company into FDA compliance. Prepared complete business plan that served as the principal strategic and operating guide for a growing baking mix producer; assisted the client in securing growth financing based on the plan. |
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