The changing world of pharmaceutical/biomedical product development As companies, large and small are challenged to cut their development times and make rapid adjustments to changing market and financial conditions new business models, epitomized by the "virtual company" have evolved. Companies with fewer permanent employees rely heavily on contract manufacturers and contract laboratories, but also on a new breed on consultants, of which I am one.   A new kind of consulting By now it is not so new anymore, but it still is distinct from the traditional consultant, i.e. "somebody from out of town with slides", who sweeps in for a day to leave you with good advice to your own devices. While I am happy to provide advice (with slides as necessary), I am prepared to see your project through and be as hands-on as necessary to "make things happen". Since my own career has evolved from an academic background to industrial research and development and management (with a good dose of exposure to government regulations) to consulting, I can understand and respond to the various challenges you face, be they of the technical, managerial or regulatory kind.   Reliable yet flexible resource in your development team Invariably your project will require a team effort. Your team may be made up of your employees, vendors, contractors or consultants or any combination thereof under one roof or on different continents. Your team may need a leader, a coordinator or a member with specific expertise. Moreover your needs may change as your project moves along. As your situation demands, I will gladly assume any of these roles as for as long or as short a time as your project requires.   Last but not least: Enthusiasm for your project and commitment to your success Projects cannot thrive without it and neither can I. Your project will have its challenges of one sort or another and overcoming technical, regulatory or managerial hurdles will make it a worthwhile endeavor and ultimately successful.