Correspondence: John Avellanet, Cerulean Associates LLC, PO Box 498, Williamsburg, VA 23187-0498, USA. Tel: +1 757 645 2864; Fax: +1 877 322 5701; E-mail: john@ceruleanllc.com; Web: www.ceruleanllc.com

¹is a leading authority on simplifying and streamlining regulatory compliance and quality system programs so clients can achieve faster time-to-market. Mr Avellanet is the co-founder and principal of the private consulting firm, Cerulean Associates LLC, an accomplished speaker and a board member for several not-for-profit industry associations. Throughout his corporate career, including a stint as a C-level executive for a medical device and biotechnology Fortune 50 subsidiary, he has been personally accountable for regulatory compliance and intellectual property security. He can be reached through his independent consultancy at www.ceruleanllc.com in Williamsburg, Virginia.

Received 21 July 2008; Revised 21 July 2008.

Abstract

In many FDA-regulated companies, the marketing and business development departments have a quietly antagonistic relationship with their quality and regulatory affairs colleagues. While compliance is supposed to ensure that a safe, efficacious and high-quality new product reaches the marketplace, marketing and business development executives are left to grumble: how are consumers – much less partners and investors – supposed to learn about and get excited about a new product if their work is so constricted? This paper suggests that there is a way to turn compliance from the millstone around Marketing's neck to the whetstone that helps hone a sharper competitive edge. HydroGel Burn Products tackled that question by shifting quality and regulatory affairs further upstream in their product development process to a point where to be overly restrictive was to stop development altogether; in other words, to a point where the focus had to be on finding a way around obstacles. The results pleased investors, partners, customers and marketers alike.