Correspondence: John Avellanet, Cerulean Associates LLC, PO Box 498, Williamsburg, Virginia 23187-0498, USA. E-mail: info@ceruleanllc.com

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

Received 1 October 2008; Revised 1 October 2008; Published online 4 November 2008.

Abstract

For the biotechnology executive looking to cut a deal with a pharmaceutical company, it is not the type of new molecule that matters, but the quality of the records and data that back up the new biotechnology drug's efficacy that matters. Executives unprepared for pharma's due diligence weaken their own negotiating hand. This paper presents three key aspects to research data quality that any prospective pharma due diligence will examine. Recommendations within the paper stress the elements of a biotechnology preparation strategy that will not only serve to prove the biotechnology's scientific quality, but will also give the biotechnology company an edge over others competing for a slice of the pharma pie.