Export compliance for life sciences

John Avellanet

DOI:https://doi.org/10.5912/jcb241

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.

Keywords:outsource ,R&D ,deemed exports ,export compliance ,FDA compliance ,compliance ,en ,