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 programmes so that 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 9 January 2008; Revised 9 January 2008; Published online 5 February 2008.

Abstract

Long before worrying about US Food and Drug Administration compliance, organisations that work with foreign employees, contractors, vendors or partners need to be concerned with the importation and exportation of technological knowledge – the so-called 'deemed exports'. This is particularly apt for executives in the biopharmaceutical, biotechnology and medical device fields who outsource research and development overseas or who hire non-US citizens. US export regulations have strict guidelines on the types of knowledge that cannot be shared with non-US citizens and carry harsh penalties for non-compliance that fall equally on the organisation in question and its executives who ought to have known better. This paper presents an eight-step strategy to develop a regulatory compliance programme that meets US export compliance regulations.