Correspondence: John Avellanet, Cerulean Associates LLC, PO Box 498, Williamsburg, Virginia 23187-0498, USA

¹is a leading authority on simplifying and streamlining regulatory compliance and quality systems, coaching executives in effective compliance programs and helping bring new medicines to market faster, easier, for less. He specializes in serving small to midsize companies, and can be directly reached through his independent consultancy, Cerulean Associates LLC at john@ceruleanllc.com.

Received 8 December 2008; Revised 8 December 2008; Published online 3 March 2009.

Abstract

Biotechnology executives frequently short-shrift one of the key indicators of return on investment when negotiating pharmaceutical partnerships, support or licensing: a compliance and quality system. Given the increasingly tight financial markets biotechnology executives must operate within, can a good quality system be established for less than the cost of an average car?